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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bag, urine collection, leg, for external use, sterile
510(k) Number K931727
Device Name URINARY DRAINAGE BAG CADDY
Applicant
NEOTECH PRODUCTS, INC.
9135 ALABAMA AVENUE, SUITE F
CHATSWORTH,  CA  91311
Applicant Contact ARNOLD HEYMAN
Correspondent
NEOTECH PRODUCTS, INC.
9135 ALABAMA AVENUE, SUITE F
CHATSWORTH,  CA  91311
Correspondent Contact ARNOLD HEYMAN
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received03/03/1993
Decision Date 07/23/1993
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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