Name: Predicase
Price: 199 USD

K-number	K040690
Device name	SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
Applicant	Cryocath Technologies, Inc.
Product code	OCL
Device class	Class II
Decision date	Apr 29, 2004
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE

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