Mya Joy PLUS Breast Pump

Pump, Breast, Powered

Ameda, Inc.

The following data is part of a premarket notification filed by Ameda, Inc. with the FDA for Mya Joy Plus Breast Pump.

Pre-market Notification Details

Device IDK203570
510k NumberK203570
Device Name:Mya Joy PLUS Breast Pump
ClassificationPump, Breast, Powered
Applicant Ameda, Inc. 485 Half Day Road; Suite 320 Buffalo Grove,  IL  60089
ContactCarolin Archibald
CorrespondentSean Gm Pettibone
Ameda, Inc. 485 Half Day Road; Suite 320 Buffalo Grove,  IL  60089
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-04-22

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