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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinometer, Mechanical
510(k) Number K934142
Device Name URINARY DRAINAGE BAG
Applicant
Key Medical Services, Inc.
5901 N. Milwaukee Ave.
Chicago,  IL  60646
Applicant Contact ROBERT E GORE
Correspondent
Key Medical Services, Inc.
5901 N. Milwaukee Ave.
Chicago,  IL  60646
Correspondent Contact ROBERT E GORE
Regulation Number876.1800
Classification Product Code
EXR  
Date Received08/25/1993
Decision Date 05/17/1994
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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