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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dilator, catheter, ureteral
510(k) Number K970041
Device Name ASCEND BALLOON DAILATION CATHETER
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 Number876.5470
Classification Product Code
EZN  
Date Received01/06/1997
Decision Date 03/19/1997
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
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