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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 K913073
Device Name DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Applicant Contact LOUIS P GOODMAN
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Correspondent Contact LOUIS P GOODMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/11/1991
Decision Date 10/25/1991
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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