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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Colonic, Metallic, Expandable
510(k) Number K990034
Device Name WILSON-COOK COLONIC Z-STENT
Applicant
MED INSTITUTE, INC.
1400 CUMBERLAND AVE.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
MED INSTITUTE, INC.
1400 CUMBERLAND AVE.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number878.3610
Classification Product Code
MQR  
Date Received01/06/1999
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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