600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA

Tubes, Gastrointestinal (and Accessories)

DELMED, INC.

The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for 600ml And 1200ml Enteral Bag Adm. Set For Frenta.

Pre-market Notification Details

Device IDK895330
510k NumberK895330
Device Name:600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick,  NJ  08903
ContactSusan Revelj
CorrespondentSusan Revelj
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 Received1989-08-31
Decision Date1990-05-02

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