Spectra Q

Pump, Breast, Powered

Uzinmedicare Co.

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

Pre-market Notification Details

Device IDK191109
510k NumberK191109
Device Name:Spectra Q
ClassificationPump, Breast, Powered
Applicant Uzinmedicare Co. Rm 105, Joongang Induspia V, Sagimakgolo 137, Jungwon-gu, Seongnam-Si, Gyeonggi-do, 13202, South Korea Seongnam-si,  KR 13202
ContactJisun Lee
CorrespondentDogyun Im
GMS Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu, Seoul, Republic Of Korea Seoul-si,  KR 03909
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
510k Review PanelObstetrics/Gynecology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-26
Decision Date2020-01-22

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