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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteroscope And Accessories
510(k) Number K993704
Device Name GASTRO-INTESTINAL SYSTEM EN-410WM
Applicant
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Applicant Contact GARY ADLER
Correspondent
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Correspondent Contact GARY ADLER
Regulation Number876.1500
Classification Product Code
FDA  
Date Received11/02/1999
Decision Date 02/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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