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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 AVENUE
SHELTON,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
FUJINON, INC.
543 LONG HILL AVENUE
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
Recalls CDRH Recalls
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