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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 K220926
Device Name Spectra Wearable
Applicant
Uzinmedicare Co., Ltd.
56, Dongtansandan 5-Gil
Hwaseong-Si,  KR 18487
Applicant Contact Jisun Lee
Correspondent
Gms Consulting
4th Floor, Digital Cube, 34, Sangamsan-Ro
Seoul,  KR 03909
Correspondent Contact Im DoGyun
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/31/2022
Decision Date 12/12/2022
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
Predetermined Change
Control Plan Authorized		 No
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