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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K961446
Device Name AQ HYDROPHILIC STENT
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number876.4620
Classification Product Code
FAD  
Date Received04/16/1996
Decision Date 05/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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