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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 K990072
Device Name BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact DEBBIE SCHMIDT
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact DEBBIE SCHMIDT
Regulation Number876.5470
Classification Product Code
EZN  
Date Received01/11/1999
Decision Date 03/25/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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