ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III

Tubes, Gastrointestinal (and Accessories)

DELMED, INC.

The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Enteral Bag Admini. Sets For Use W/flexiflo-iii.

Pre-market Notification Details

Device IDK895919
510k NumberK895919
Device Name:ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick,  NJ  08903
ContactMichele Dziedzic
CorrespondentMichele Dziedzic
DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick,  NJ  08903
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-10
Decision Date1990-05-02

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