Code of Federal Regulations · Section
§ 886.3340 — Extraocular Orbital Implant
21 C.F.R. § 886.3340
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351