SOEHENDRA STENT RETRIEVER

Stents, Drains And Dilators For The Biliary Ducts

WILSON-COOK MEDICAL, INC.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Soehendra Stent Retriever.

Pre-market Notification Details

Device IDK903420
510k NumberK903420
Device Name:SOEHENDRA STENT RETRIEVER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
ContactRichard Marshall
CorrespondentRichard Marshall
WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-31
Decision Date1990-10-22

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