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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, biopsy, electric
510(k) Number K220053
Device Name Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
FUJIFILM Healthcare Americas Corporation
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Dhara Buch
Regulation Number876.4300
Classification Product Code
Date Received01/06/2022
Decision Date 02/04/2022
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