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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 K242111
Device Name VIVACE
Applicant
Unimom.Co
110-19, Gajangsaneopseobuk-Ro
Osan-Si,  KR 18102
Applicant Contact Yeong-Bin Chon
Correspondent
Unimom.Co
110-19, Gajangsaneopseobuk-Ro
Osan-Si,  KR 18102
Correspondent Contact Yeong-Bin Chon
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/19/2024
Decision Date 02/06/2025
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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