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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Air, Non-Manual, For Endoscope
510(k) Number K153362
Device Name AquaShield system CO2, AquaShield system-PENTAX
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY ROAD
MENTOR,  OH  44060
Applicant Contact CARROLL MARTIN
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY ROAD
MENTOR,  OH  44060
Correspondent Contact CARROLL MARTIN
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received11/20/2015
Decision Date 12/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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