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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 K221264
Device Name FROG Forceps Valve (VAL1-F1-100)
Applicant
Fujifilm Medwork GmbH
Medworkring 1
Hochstadt,  DE 91315
Applicant Contact Randy Vader
Correspondent
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave.
Suite 300
Lexington,  MA  02421
Correspondent Contact Dhara Buch
Regulation Number876.1500
Classification Product Code
ODC  
Date Received05/02/2022
Decision Date 06/01/2022
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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