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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, urine drainage, closed, for nonindwelling catheter, sterile
510(k) Number K951597
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 Number876.5250
Classification Product Code
EYZ  
Date Received04/07/1995
Decision Date 08/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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