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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR886.5842]
See Related Information on Spectacle frame. 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 F--Therapeutic Devices

Sec. 886.5842 Spectacle frame.

(a)Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

(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.

[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]

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