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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, breast, powered
510(k) Number K191109
Device Name Spectra Q
Applicant
Uzinmedicare Co.
Rm 105, Joongang Induspia V, Sagimakgolo 137,
Jungwon-gu, Seongnam-Si, Gyeonggi-do, 13202, South Korea
Seongnam-si,  KR 13202
Applicant Contact Jisun Lee
Correspondent
GMS Consulting Co., Ltd.
34, Sangamsan-ro, Mapo-gu, Seoul, Republic of Korea
Seoul-si,  KR 03909
Correspondent Contact Dogyun Im
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/26/2019
Decision Date 01/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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