K-number	K240457
Device name	C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
Applicant	Pentax of America, Inc.
Product code	GEH
Device class	Class II
Decision date	Jul 24, 2024
Decision	Substantially Equivalent
Regulation	878.4350

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View the full FDA submission: accessdata.fda.gov

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C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

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