Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty

Pump, Breast, Powered

MEDELA AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty.

Pre-market Notification Details

Device IDK150499
510k NumberK150499
Device Name:Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty
ClassificationPump, Breast, Powered
Applicant MEDELA AG LATTICHSTRASSE 4B Baar,  CH 6341
ContactOrlando Antunes
CorrespondentAdrienne Lenz
PATHWAY REGULATORY CONSULTING, LLC W324S3649 COUNTY ROAD E Dousman,  WI  53118
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-26
Decision Date2015-04-21
Summary:summary

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