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§884.4500. Obstetric fetal destructive instrument.

21 C.F.R. § 884.4500

(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).
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.