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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Esophageal
510(k) Number K933845
Device Name WILSON-COOK BALLOON INFLATION DEVICE
Applicant
Wilson-Cook Medical, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
Wilson-Cook Medical, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number876.5365
Classification Product Code
KNQ  
Date Received08/06/1993
Decision Date 11/29/1994
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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