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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR886.1680]
 See Related Information on 886.1680 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. 886.1680 Ophthalmic projector.

(a)Identification. An ophthalmic projector is an AC-powered device intended to project an image on a screen for vision testing.

(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.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]

 
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