Evolve Breast Pump

Pump, Breast, Powered

Hygeia II Medical Group, Inc.

The following data is part of a premarket notification filed by Hygeia Ii Medical Group, Inc. with the FDA for Evolve Breast Pump.

Pre-market Notification Details

Device IDK200406
510k NumberK200406
Device Name:Evolve Breast Pump
ClassificationPump, Breast, Powered
Applicant Hygeia II Medical Group, Inc. 6241 Yarrow Drive Carlsbad,  CA  92011
ContactBrett Nakfoor
CorrespondentBrett Nakfoor
Hygeia II Medical Group, Inc. 6241 Yarrow Drive Carlsbad,  CA  92011
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-19
Decision Date2020-03-18

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