K-number	K892071
Device name	GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE
Applicant	Amedic USA
Product code	KNW
Device class	Class II
Decision date	Aug 8, 1989
Decision	Substantially Equivalent
Regulation	876.1075

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View the full FDA submission: accessdata.fda.gov

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GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE

Everything you need for a 510(k) submission. Nothing you don't.