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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K193036
Device Name C2 CryoBalloon EndoGrip
Applicant
Pentax Medical, A Division of Pentax of America, Inc.
303 Convention Way, Suite 1
Redwood, Ca,  CA  94063
Applicant Contact Gurvinder Singh Nanda
Correspondent
Pentax Medical, A Division of Pentax of America, Inc.
303 Convention Way, Suite 1
Redwood, Ca,  CA  94063
Correspondent Contact Gurvinder Singh Nanda
Regulation Number876.1500
Classification Product Code
OCX  
Date Received10/31/2019
Decision Date 11/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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