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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K961897
Device Name WILSON-COOK BILIARY INTRODUCER WITH ASPIRATION BIOPSY NEEDLE
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 Number876.1075
Classification Product Code
FCG  
Subsequent Product Code
FBK  
Date Received05/16/1996
Decision Date 01/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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