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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
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 | 878.1 | Scope. |
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| 878.3 | Effective dates of requirement for premarket approval. |
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| 878.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 878.1800 | Speculum and accessories. |
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| 878.3250 | External facial fracture fixation appliance. |
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| 878.3300 | Surgical mesh. |
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| 878.3500 | Polytetrafluoroethylene with carbon fibers composite implant material. |
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| 878.3530 | Silicone inflatable breast prosthesis. |
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| 878.3540 | Silicone gel-filled breast prosthesis. |
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| 878.3550 | Chin prosthesis. |
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| 878.3590 | Ear prosthesis. |
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| 878.3610 | Esophageal prosthesis. |
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| 878.3680 | Nose prosthesis. |
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| 878.3720 | Tracheal prosthesis. |
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| 878.3750 | External prosthesis adhesive. |
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| 878.3800 | External aesthetic restoration prosthesis. |
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| 878.3900 | Inflatable extremity splint. |
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| 878.3910 | Noninflatable extremity splint. |
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| 878.3925 | Plastic surgery kit and accessories. |
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| 878.4040 | Surgical apparel. |
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| 878.4100 | Organ bag. |
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| 878.4160 | Surgical camera and accessories. |
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| 878.4200 | Introduction/drainage catheter and accessories. |
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| 878.4300 | Implantable clip. |
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| 878.4320 | Removable skin clip. |
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| 878.4350 | Cryosurgical unit and accessories. |
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| 878.4370 | Surgical drape and drape accessories. |
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| 878.4380 | Drape adhesive. |
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| 878.4400 | Electrosurgical cutting and coagulation device and accessories. |
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| 878.4440 | Eye pad. |
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| 878.4450 | Nonabsorbable gauze for internal use. |
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| 878.4460 | Surgeon's glove. |
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| 878.4470 | Surgeon's gloving cream. |
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| 878.4480 | Absorbable powder for lubricating a surgeon's glove. |
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| 878.4490 | Absorbable hemostatic agent and dressing. |
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| 878.4493 | Absorbable poly(glycolide/L-lactide) surgical suture. |
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| 878.4520 | Polytetrafluoroethylene injectable. |
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| 878.4580 | Surgical lamp. |
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| 878.4630 | Ultraviolet lamp for dermatologic disorders. |
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| 878.4635 | Ultraviolet lamp for tanning. |
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| 878.4660 | Skin marker. |
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| 878.4680 | Nonpowered, single patient, portable suction apparatus. |
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| 878.4700 | Surgical microscope and accessories. |
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| 878.4730 | Surgical skin degreaser or adhesive tape solvent. |
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| 878.4750 | Implantable staple. |
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| 878.4760 | Removable skin staple. |
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| 878.4780 | Powered suction pump. |
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| 878.4800 | Manual surgical instrument for general use. |
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| 878.4810 | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
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| 878.4820 | Surgical instrument motors and accessories/attachments. |
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| 878.4830 | Absorbable surgical gut suture. |
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| 878.4930 | Suture retention device. |
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| 878.4950 | Manual operating table and accessories and manual operating chair and accessories. |
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| 878.4960 | Operating tables and accessories and operating chairs and accessories. |
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| 878.5000 | Nonabsorbable poly(ethylene terephthalate) surgical suture. |
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| 878.5010 | Nonabsorbable polypropylene surgical suture. |
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| 878.5020 | Nonabsorbable polyamide surgical suture. |
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| 878.5030 | Natural nonabsorbable silk surgical suture. |
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| 878.5040 | Suction lipoplasty system. |
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| 878.5070 | Air-handling apparatus for a surgical operating room. |
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| 878.5350 | Needle-type epilator. |
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| 878.5360 | Tweezer-type epilator. |
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| 878.5650 | Topical oxygen chamber for extremities. |
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| 878.5900 | Nonpneumatic tourniquet. |
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| 878.5910 | Pneumatic tourniquet. |
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