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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 D: Prosthetic Devices
886.3130 - Ophthalmic conformer.
(a) Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to ? 886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
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