MEGNA BREAST PUMPS

Pump, Breast, Powered

WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.

The following data is part of a premarket notification filed by Wuxi Xinzhongrui Baby Supplies Co., Ltd. with the FDA for Megna Breast Pumps.

Pre-market Notification Details

Device IDK142479
510k NumberK142479
Device Name:MEGNA BREAST PUMPS
ClassificationPump, Breast, Powered
Applicant WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT Wuxi City,  CN 214000
ContactAnne Chen
CorrespondentDavid Zeng
MEGNA INC. 1043 ANDREW DRIVE West Chester,  PA  19380
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-04
Decision Date2015-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.