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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 K162870
Device Name CIMLRE F1 and CIMILRE S3
Applicant
Cimilre Co., Ltd.
#201, 202, Sagimakgol-Ro 148, Jungwon-Gu
Seongnam-Si,  KR 13207
Applicant Contact Ko Bong Jae
Correspondent
Cimilre Co., Ltd.
#201, 202, Sagimakgol-Ro 148, Jungwon-Gu
Seongnam-Si,  KR 13207
Correspondent Contact Ko Bong Jae
Regulation Number884.5160
Classification Product Code
HGX  
Date Received10/13/2016
Decision Date 03/07/2017
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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