Name: Predicase
Price: 199 USD

K-number	K011971
Device name	NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
Applicant	Image-Guided Neurologics, Inc.
Product code	HAW
Device class	Class II
Decision date	Aug 3, 2001
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000

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