Code of Federal Regulations · Section
§ 884.4500 — Obstetric Fetal Destructive Instrument
21 C.F.R. § 884.4500
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(a) Identification. An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351