FRENTA(R) DUO-SET

Tubes, Gastrointestinal (and Accessories)

DELMED, INC.

The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Frenta(r) Duo-set.

Pre-market Notification Details

Device IDK895246
510k NumberK895246
Device Name:FRENTA(R) DUO-SET
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick,  NJ  08903
ContactRevelj, R.n.
CorrespondentRevelj, R.n.
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 Received1989-08-21
Decision Date1990-05-02

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