K-number	K854404
Device name	ROTEX SCREW BIOPSY NEEDLE
Applicant	Meadox Surgimed, Inc.
Product code	FCG
Device class	Class II
Decision date	Dec 2, 1985
Decision	Substantially Equivalent
Regulation	876.1075

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View the full FDA submission: accessdata.fda.gov

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ROTEX SCREW BIOPSY NEEDLE

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