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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 886: OPHTHALMIC DEVICES
Subpart F: Therapeutic Devices
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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