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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 K895330
Device Name 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
Applicant
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Applicant Contact SUSAN REVELJ
Correspondent
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Correspondent Contact SUSAN REVELJ
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/31/1989
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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