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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
Recalls CDRH Recalls
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