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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name choledochoscope and accessories, flexible/rigid
510(k) Number K933906
Device Name CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
Applicant
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Applicant Contact GARY A ADLER
Correspondent
FUJINON, INC.
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Correspondent Contact GARY A ADLER
Regulation Number876.1500
Classification Product Code
FBN  
Date Received08/11/1993
Decision Date 07/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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