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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
[CITE: 21CFR886.1880]
 See Related Information on 886.1880 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 886 -- OPHTHALMIC DEVICES

Subpart B--Diagnostic Devices
Sec. 886.1880 Fusion and stereoscopic target.

(a)Identification. A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (886.1870).

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]

Database Updated April 1, 2008

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