SPECTRA SERIES BREAST PUMP

Pump, Breast, Powered

UZINMEDICARE CO.

The following data is part of a premarket notification filed by Uzinmedicare Co. with the FDA for Spectra Series Breast Pump.

Pre-market Notification Details

Device IDK093145
510k NumberK093145
Device Name:SPECTRA SERIES BREAST PUMP
ClassificationPump, Breast, Powered
Applicant UZINMEDICARE CO. 503 -2 CHANG-RI, NAMSA -MYEON Yongin,  KR 449-885
ContactYong J Choi
CorrespondentYong J Choi
UZINMEDICARE CO. 503 -2 CHANG-RI, NAMSA -MYEON Yongin,  KR 449-885
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-05
Decision Date2010-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851690007028 K093145 000
00851690007004 K093145 000
18809108011340 K093145 000
28809108010593 K093145 000

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