Name: Predicase
Price: 199 USD

K-number	K081323
Device name	BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
Applicant	B-K Medical Aps
Product code	FCG
Device class	Class II
Decision date	Jul 22, 2008
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818

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