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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K232314
Device Name Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
Applicant
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue
Suite 300
Lexington,  MA  02421
Applicant Contact Chaitrali Kulkarni
Correspondent
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue
Suite 300
Lexington,  MA  02421
Correspondent Contact Chaitrali Kulkarni
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received08/02/2023
Decision Date 09/01/2023
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
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