Code of Federal Regulations · Section
§ 868.5830 — Autotransfusion Apparatus
21 C.F.R. § 868.5830
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(a) Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351