§882.4545. Shunt system implantation instrument.
21 C.F.R. § 882.4545
Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Notes, amendments, and revision history
Amendments
[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.
Amendments
[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]