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CRYOBALLOON FOCAL ABLATION SYSTEM

C2 Therapeutics · Class II · Cleared Aug 22, 2013

K-numberK131523
Device nameCRYOBALLOON FOCAL ABLATION SYSTEM
ApplicantC2 Therapeutics
Product codeGEH
Device classClass II
Decision dateAug 22, 2013
DecisionSubstantially Equivalent
Regulation878.4350
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Source

View the full FDA submission: accessdata.fda.gov

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