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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irrigator, Ostomy
510(k) Number K914692
Device Name URINARY DIVERSION EVACUATING 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 Number876.5895
Classification Product Code
EXD  
Date Received10/18/1991
Decision Date 07/02/1992
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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