Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart D - Prosthetic Devices / § 886.3340 Extraocular orbital implant.
§ 886.3340 Extraocular orbital implant.
(a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
(b) Classification. Class II.