K-number	K193036
Device name	C2 CryoBalloon EndoGrip
Applicant	Pentax Medical, A Division of Pentax of America, Inc.
Product code	OCX
Device class	Class II
Decision date	Nov 22, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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C2 CryoBalloon EndoGrip

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