WILSON-COOK VARICES TAMPONADE BALLOON CUFF

Tubes, Gastrointestinal (and Accessories)

WILSON-COOK MEDICAL, INC.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Wilson-cook Varices Tamponade Balloon Cuff.

Pre-market Notification Details

Device IDK902099
510k NumberK902099
Device Name:WILSON-COOK VARICES TAMPONADE BALLOON CUFF
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-08
Decision Date1990-11-07

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