Name: Predicase
Price: 199 USD

K-number	K090120
Device name	REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
Applicant	Biosense Webster, Inc.
Product code	DRF
Device class	Class II
Decision date	Mar 24, 2009
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106

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