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FDA 510(k) Applications Submitted by PENTAX Medical, A Division of PENTAX of America, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190194
02/04/2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
PENTAX Medical, A Division of PENTAX of America, Inc.
K193036
10/31/2019
C2 CryoBalloon EndoGrip
PENTAX Medical, A Division of PENTAX of America, Inc.
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