Code of Federal Regulations · Section
§ 880.6880 — Steam Sterilizer
21 C.F.R. § 880.6880
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(a) Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351