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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 K990130
Device Name WILSON-COOK PANCREATIC WEDGE STENT
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Applicant Contact PAULA JOYCE
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM,  NC  27105
Correspondent Contact PAULA JOYCE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/14/1999
Decision Date 02/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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