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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K912047
Device Name WILSON-COOK RUSSELL GASTROSTOMY KIT
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd. &
5951 Grassy Creek Blvd.
Winston-Salem,  NC  27105
Applicant Contact RICHARD F MARSHALL
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd. &
5951 Grassy Creek Blvd.
Winston-Salem,  NC  27105
Correspondent Contact RICHARD F MARSHALL
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/09/1991
Decision Date 09/05/1991
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
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