21 CFR 882.4545 - Shunt system implantation instrument.

§ 882.4545 Shunt system implantation instrument.

(a)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.

(b)Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.

[ 44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]

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