§882.5910. Dura substitute.

21 C.F.R. § 882.5910

(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).

Notes, amendments, and revision history

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.