K193036

Substantially Equivalent

C2 CryoBalloon EndoGrip

Applicant: Pentax Medical, A Division of Pentax of America, Inc.
Product code: OCX
Advisory panel: Gastroenterology, Urology
Date received: 2019-10-31
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood, Ca, CA, US

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