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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K042076
FOIA Releasable 510(k) K042076
Device Name FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
Applicant
Fujinon, Inc.
P.O. Box 2156
Huntington,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
Fujinon, Inc.
P.O. Box 2156
Huntington,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number876.1500
Classification Product Code
FDT  
Date Received08/02/2004
Decision Date 11/18/2004
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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