Code of Federal Regulations · Section
§ 868.5260 — Breathing Circuit Bacterial Filter
21 C.F.R. § 868.5260
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(a) Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351