Name: Predicase
Price: 199 USD

K-number	K062140
Device name	SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
Applicant	Cryocath Technologies, Inc.
Product code	OCL
Device class	Class II
Decision date	Aug 24, 2006
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1

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