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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 K896448
Device Name BALLOON DILATION CATHETER
Applicant
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
Cook Ob/Gyn
1100 W. Morgan St.
P.O. Box 271
Spencer,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number876.5470
Classification Product Code
EZN  
Date Received11/09/1989
Decision Date 03/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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