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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K212950
Device Name FUJIFILM Video Laparoscope EL-R740M30
Applicant
FUJIFILM Corporaton
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun,  JP 258-8538
Applicant Contact Randy Vader
Correspondent
FUJIFILM Medical Systems U.S.A, Inc.
81 Hartwell Avenue, Suite 300
Lexington,  MA  02421
Correspondent Contact Dhara Buch
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/16/2021
Decision Date 12/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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