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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 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
Correspondent 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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