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e-CFR Data is current as of February 12, 2009
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
Subpart A--GENERAL PROVISIONS
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Effective dates of requirement for premarket approval. |
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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Subpart B--DIAGNOSTIC DEVICES
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Speculum and accessories. |
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Subpart C--[RESERVED]
Subpart D--PROSTHETIC DEVICES
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External facial fracture fixation appliance. |
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Polytetrafluoroethylene with carbon fibers composite implant material. |
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Silicone inflatable breast prosthesis. |
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Silicone gel-filled breast prosthesis. |
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External prosthesis adhesive. |
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External aesthetic restoration prosthesis. |
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Inflatable extremity splint. |
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Noninflatable extremity splint. |
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Plastic surgery kit and accessories. |
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Subpart E--SURGICAL DEVICES
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Nonresorbable gauze/sponge for external use. |
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Hydrophilic wound dressing. |
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Occlusive wound dressing. |
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Hydrogel wound dressing and burn dressing. |
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Surgical camera and accessories. |
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Introduction/drainage catheter and accessories. |
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Cryosurgical unit and accessories. |
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Surgical drape and drape accessories. |
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Electrosurgical cutting and coagulation device and accessories. |
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Low energy ultrasound wound cleaner. |
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Nonabsorbable gauze for internal use. |
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Absorbable powder for lubricating a surgeon's glove. |
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Absorbable hemostatic agent and dressing. |
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Absorbable poly(glycolide/-lactide) surgical suture. |
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Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology. |
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Polytetrafluoroethylene injectable. |
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Ultraviolet lamp for dermatologic disorders. |
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Ultraviolet lamp for tanning. |
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Nonpowered, single patient, portable suction apparatus. |
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Surgical microscope and accessories. |
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Surgical skin degreaser or adhesive tape solvent. |
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Manual surgical instrument for general use. |
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Laser surgical instrument for use in general and plastic surgery and in dermatology. |
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Surgical instrument motors and accessories/attachments. |
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Absorbable surgical gut suture. |
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Absorbable polydioxanone surgical suture. |
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Manual operating table and accessories and manual operating chair and accessories. |
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Operating tables and accessories and operating chairs and accessories. |
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Nonabsorbable poly(ethylene terephthalate) surgical suture. |
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Nonabsorbable polypropylene surgical suture. |
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Nonabsorbable polyamide surgical suture. |
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Natural nonabsorbable silk surgical suture. |
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Nonabsorbable expanded polytetrafluoroethylene surgical suture. |
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Suction lipoplasty system. |
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Subpart F--THERAPEUTIC DEVICES
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Air-handling apparatus for a surgical operating room. |
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Topical oxygen chamber for extremities. |
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