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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 K162749
Device Name FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
Applicant
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Applicant Contact Shraddha S. More
Correspondent
Fujifilm Medical Systems U.S.A, Inc.
10 High Pt. Dr.
Wayne,  NJ  07470
Correspondent Contact Shraddha S. More
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received09/30/2016
Decision Date 06/15/2017
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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