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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K852490
Device Name URI-CATH SYSTEM
Applicant
Gesco Intl., Inc.
P.O. Box 690188
San Antonio,  TX  78269
Applicant Contact GEORGE E SINKO
Correspondent
Gesco Intl., Inc.
P.O. Box 690188
San Antonio,  TX  78269
Correspondent Contact GEORGE E SINKO
Regulation Number876.5250
Classification Product Code
KNX  
Date Received06/12/1985
Decision Date 11/05/1985
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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