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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, biliary, diagnostic
510(k) Number K935094
FOIA Releasable 510(k) K935094
Device Name BALLOON DILATION CATHETER
Applicant
WILSON-COOK MEDICAL, INC.
4900 bethania station rd. &
5951 grassy creek blvd.
winston-salem,  NC  27105
Applicant Contact paula a joyce
Correspondent
WILSON-COOK MEDICAL, INC.
4900 bethania station rd. &
5951 grassy creek blvd.
winston-salem,  NC  27105
Correspodent Contact paula a joyce
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received10/22/1993
Decision Date 01/24/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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