Freestyle Flex

Pump, Breast, Powered

Medela AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for Freestyle Flex.

Pre-market Notification Details

Device IDK191653
510k NumberK191653
Device Name:Freestyle Flex
ClassificationPump, Breast, Powered
Applicant Medela AG Laettichstrasse 4b Baar Zug,  CH Ch-6341
ContactJudith Bernardo
CorrespondentAdrienne Lenz
Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington,  DC  20005
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-20
Decision Date2019-10-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07612367071918 K191653 000
07612367071727 K191653 000
07612367071734 K191653 000

Trademark Results [Freestyle Flex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE FLEX
FREESTYLE FLEX
79268008 not registered Live/Pending
Medela Holding AG
2019-06-27

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