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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
Recalls CDRH Recalls
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