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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 K180075
Device Name MINUET LCD, MINUET LCD eco
Applicant
Unimom.Co
110-19, Gajangsaneopseobuk-Ro
Osan-Si,  KR 18102
Applicant Contact Hong Sang-Hyun
Correspondent
Unimom.Co
110-19, Gajangsaneopseobuk-Ro
Osan-Si,  KR 18102
Correspondent Contact Sang-Hyun Hong
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/10/2018
Decision Date 08/06/2018
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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