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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K002650
Device Name VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
Applicant
BENTEC MEDICAL, INC.
1380 EAST BEAMER ST.
WOODLAND,  CA  95776
Applicant Contact DAVID TUCKER
Correspondent
BENTEC MEDICAL, INC.
1380 EAST BEAMER ST.
WOODLAND,  CA  95776
Correspondent Contact DAVID TUCKER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/25/2000
Decision Date 02/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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