Code of Federal Regulations · Section
§ 882.5910 — Dura Substitute
21 C.F.R. § 882.5910
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(a) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351