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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 K962652
Device Name URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
Applicant
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Applicant Contact OSVALDO RODRIGUEZ
Correspondent
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Correspondent Contact OSVALDO RODRIGUEZ
Regulation Number876.5250
Classification Product Code
KNX  
Date Received07/08/1996
Decision Date 10/04/1996
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
Recalls CDRH Recalls
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