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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope Channel Accessory
510(k) Number K210625
Device Name JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
Applicant
Fujifilm Medwork GmbH
Medworkring 1
Hochstadt,  DE 91315
Applicant Contact Randy Vader
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
81 Hartwell Ave.
Suite 300
Lexington,  MA  02421
Correspondent Contact Jeffrey Wan
Regulation Number876.1500
Classification Product Code
ODC  
Subsequent Product Code
FDF  
Date Received03/02/2021
Decision Date 09/10/2021
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
Predetermined Change
Control Plan Authorized		 No
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