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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 K901320
Device Name ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG
Applicant
Ep Medical, Inc.
139 York Ave.
Kensington,  CA  94707
Applicant Contact DIANNE EASTMAN
Correspondent
Ep Medical, Inc.
139 York Ave.
Kensington,  CA  94707
Correspondent Contact DIANNE EASTMAN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received03/21/1990
Decision Date 01/25/1991
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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