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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 K894867
Device Name WILTEK E.R.C.P. 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 Received07/31/1989
Decision Date 12/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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