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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
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