Name: Predicase
Price: 199 USD

K-number	K021707
Device name	SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
Applicant	Senorx, Inc.
Product code	KNW
Device class	Class II
Decision date	Aug 14, 2002
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS

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