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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K915443
Device Name URODYNAMIC CATHETER
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number876.1620
Classification Product Code
FAP  
Date Received12/05/1991
Decision Date 02/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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