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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 K041903
Device Name FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
Applicant
Fujinon, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Fujinon, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number876.1500
Classification Product Code
FDF  
Date Received07/14/2004
Decision Date 11/10/2004
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
Recalls CDRH Recalls
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