Symphony Breastpump, Symphony Reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery Version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental

Pump, Breast, Powered

MEDELA AG

The following data is part of a premarket notification filed by Medela Ag with the FDA for Symphony Breastpump, Symphony Reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery Version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental.

Pre-market Notification Details

Device IDK151632
510k NumberK151632
Device Name:Symphony Breastpump, Symphony Reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery Version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental
ClassificationPump, Breast, Powered
Applicant MEDELA AG LATTICHSTRASSE 4B Baar,  CH 6341
ContactOrlando Antunes
CorrespondentAdrienne Lenz
PATHWAY REGULATORY CONSULTING, LLC W324 S3649 COUNTY ROAD E Dousman,  WI  53118
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-17
Decision Date2015-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07612367007566 K151632 000

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