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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 K040048
Device Name FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
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
FDA  
Subsequent Product Code
KNT  
Date Received01/12/2004
Decision Date 06/07/2004
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
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