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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Cystometric, Hydraulic
510(k) Number K930135
Device Name SILICONE RECTAL BALLOON
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number876.1620
Classification Product Code
FEN  
Date Received01/12/1993
Decision Date 10/08/1993
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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