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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K133077
Device Name GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
Applicant
Generica Medical International, Inc.
1910 D St.
La Verne,  CA  91750
Applicant Contact JIM BARLEY
Correspondent
Generica Medical International, Inc.
1910 D St.
La Verne,  CA  91750
Correspondent Contact JIM BARLEY
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
FPD  
Date Received09/30/2013
Decision Date 07/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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