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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colonoscope and accessories, flexible/rigid
510(k) Number K112391
Device Name FUJINON COLONOSCOPES
Applicant
FUJINON, INC.
10 HIGH POINT DR.
WAYNE,  NJ  07470
Applicant Contact GINA WALLJASPER
Correspondent
FUJINON, INC.
10 HIGH POINT DR.
WAYNE,  NJ  07470
Correspondent Contact GINA WALLJASPER
Regulation Number876.1500
Classification Product Code
FDF  
Date Received08/19/2011
Decision Date 07/26/2012
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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