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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 K823450
Device Name FEMALE EXTERNAL URINARY APPLIANCE
Applicant
Diamed Division Ill. Tool Works, Inc.
Burditt & Calkins
135 S. Lasalle
Chicago,  IL  60603
Applicant Contact R RADZIUS
Correspondent
Diamed Division Ill. Tool Works, Inc.
Burditt & Calkins
135 S. Lasalle
Chicago,  IL  60603
Correspondent Contact R RADZIUS
Regulation Number876.5250
Classification Product Code
KNX  
Date Received11/17/1982
Decision Date 12/28/1982
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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