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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K944759
Device Name 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
Applicant
FUJINON, INC.
10 HIGH POINT DR.
wayne,  NJ  07470
Applicant Contact h j evans
Correspondent
FUJINON, INC.
10 HIGH POINT DR.
wayne,  NJ  07470
Correspondent Contact h j evans
Regulation Number876.1500
Classification Product Code
FET  
Subsequent Product Codes
FDF   FDS   FDT   GCT  
Date Received09/27/1994
Decision Date 04/11/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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