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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 K133976
Device Name FUJIFILM ENDOSCOPIC CO2 REGULATOR
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Applicant Contact GINA WALLJASPER
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Correspondent Contact GINA WALLJASPER
Regulation Number876.1500
Classification Product Code
FCX  
Date Received12/26/2013
Decision Date 09/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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