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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 K211016
Device Name Powered Breast Pump (Models 7V and 7X)
Applicant
Haenim Co., Ltd.
15, Saryeom-Ro 21beon-Gil, Seo-Gu
Incheon,  KR 22742
Applicant Contact Dae Won Kim
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/05/2021
Decision Date 06/29/2022
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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