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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 K941350
Device Name WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
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 Received03/21/1994
Decision Date 03/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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