K-number	K160994
Device name	C2 CryoBalloon Focal Pear Catheter
Applicant	C2 Therapeutics, Inc.
Product code	GEH
Device class	Class II
Decision date	May 19, 2016
Decision	Substantially Equivalent
Regulation	878.4350

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View the full FDA submission: accessdata.fda.gov

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C2 CryoBalloon Focal Pear Catheter

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