K-number	K890327
Device name	BIOPSY NEEDLE GUIDE ATTACHMENT
Applicant	Elscint, Inc.
Product code	FCG
Device class	Class II
Decision date	Mar 8, 1989
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPSY NEEDLE GUIDE ATTACHMENT

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