ENTECH ENTERAL PUMP AND SET

Pump, Infusion

ENTECH, INC.

The following data is part of a premarket notification filed by Entech, Inc. with the FDA for Entech Enteral Pump And Set.

Pre-market Notification Details

Device IDK873444
510k NumberK873444
Device Name:ENTECH ENTERAL PUMP AND SET
ClassificationPump, Infusion
Applicant ENTECH, INC. ROUTE 22 EAST Lebanon,  NJ  08833
ContactLaurence A Potter
CorrespondentLaurence A Potter
ENTECH, INC. ROUTE 22 EAST Lebanon,  NJ  08833
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-27
Decision Date1987-11-02

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