ENTERAL ADMINISTRATION SET

Tube, Feeding

PLASCO, INC.

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

Pre-market Notification Details

Device IDK870623
510k NumberK870623
Device Name:ENTERAL ADMINISTRATION SET
ClassificationTube, Feeding
Applicant PLASCO, INC. 3849 SWANSON ST. Gurnee,  IL  60031 -1225
ContactMichael S Feles
CorrespondentMichael S Feles
PLASCO, INC. 3849 SWANSON ST. Gurnee,  IL  60031 -1225
Product CodeFPD  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-12
Decision Date1987-06-26

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