SUPPLEMENTAL FEEDING SYSTEM

Pump, Breast, Non-powered

MEDELA, INC.

The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Supplemental Feeding System.

Pre-market Notification Details

Device IDK844297
510k NumberK844297
Device Name:SUPPLEMENTAL FEEDING SYSTEM
ClassificationPump, Breast, Non-powered
Applicant MEDELA, INC. 6711 SANDS RD. Crystal Lake,  IL  60014
ContactGotthilf Weiniger
CorrespondentGotthilf Weiniger
MEDELA, INC. 6711 SANDS RD. Crystal Lake,  IL  60014
Product CodeHGY  
CFR Regulation Number884.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-29
Decision Date1985-02-25

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