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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 K202045
Device Name imani i1
Applicant
imani Co.
1F, Na Dong, 19, Wanjangcheon-ro 394beon-gil, Namsa-myeon,
Cheoin-gu
Yongin-si,  KR 17117
Applicant Contact Hyo-Soon Hwang
Correspondent
Global Medical Standard Consulting Co., Ltd.
34, Sangamsan-ro, Mapo-gu
Seoul,  KR 03909
Correspondent Contact Do Gyun Lim
Regulation Number884.5160
Classification Product Code
HGX  
Date Received07/23/2020
Decision Date 02/26/2021
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
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