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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: 21CFR886.5918]
 See Related Information on 886.5918 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. 886.5918 Rigid gas permeable contact lens care products.

(a)Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

(b)Classification. Class II (Special Controls) Guidance Document: "Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."

[62 FR 30987, June 6, 1997]

 
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