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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 K895919
Device Name ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
Applicant
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Applicant Contact MICHELE DZIEDZIC
Correspondent
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Correspondent Contact MICHELE DZIEDZIC
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/10/1989
Decision Date 05/02/1990
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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