DOBBHOFF BILIARY STENT SET

Stents, Drains And Dilators For The Biliary Ducts

BIOSEARCH MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Dobbhoff Biliary Stent Set.

Pre-market Notification Details

Device IDK901582
510k NumberK901582
Device Name:DOBBHOFF BILIARY STENT SET
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
ContactPeter Waeger
CorrespondentPeter Waeger
BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville,  NJ  08876
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-04
Decision Date1990-06-22

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