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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 K914881
Device Name WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
Applicant
WILTEK MEDICAL, INC.
P.O.BOX 11946
WINSTON-SALEM,  NC  27116
Applicant Contact JON S WILSON
Correspondent
WILTEK MEDICAL, INC.
P.O.BOX 11946
WINSTON-SALEM,  NC  27116
Correspondent Contact JON S WILSON
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/30/1991
Decision Date 01/07/1992
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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