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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 K163183
Device Name Yooeehouse Breast Pump
Applicant
Nantong Poly Technology Co., Ltd.
No.332, Xinxing Road, Development Zone
Nantong,  CN 226010
Applicant Contact Rongmin Lin
Correspondent
MEDWHEAT (SHANGHAI) MEDICAL TECHNOLOGY CO.,LTD..
YANGPU DISTRICT LIAOYUAN EAST ROAD SHUANGYANG
FIRST SUITE NO.33 ROOM 303
SHANGHAI,  CN 200093
Correspondent Contact Jonathan Hu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/14/2016
Decision Date 10/02/2017
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
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