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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K180711
Device Name FUJIFILM Endoscopic CO2 Regulator GW-100
Applicant
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigara Kami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
40 Boroline Rd.
Allendale,  NJ  07401
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
FCX  
Date Received03/19/2018
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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