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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 K251423
Device Name Spectra S1 Pro; Spectra S2 Pro
Applicant
Uzinmedicare Co., Ltd.
56, Dongtansandan 5-Gil, Hwaseong-Si
Gyeonggi-Do,  KR 18487
Applicant Contact Soyeon Lim
Correspondent
GMSC Co., Ltd.
66, Cheongcho-Ro, Deogyang-Gu, Goyang-Si
Gyeonggi-Do,  KR 10543
Correspondent Contact Jong-Hyun Kim
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/08/2025
Decision Date 02/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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