K-number	K101825
Device name	CRYOBALLOON ABLATION SYSTEM
Applicant	C2 Therapeutics
Product code	GEH
Device class	Class II
Decision date	Sep 29, 2010
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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CRYOBALLOON ABLATION SYSTEM

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