Name: Predicase
Price: 199 USD

K-number	K030303
Device name	FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
Applicant	Cryocath Technologies, Inc.
Product code	GEH
Device class	Class II
Decision date	Apr 29, 2003
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE

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