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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 K201152
Device Name Electric Breast Pump
Guangdong Horigen Mother & Baby Products Co., Ltd.
Block A&B&C, NCBC Industrial Park, 6th Baolong Road,
Longgang District,
Shantou,  CN 515100
Applicant Contact Jun Deng
Guangzhou Osmunda Medical Device Technical Service Co., Ltd
8-9th Floor, R&D Building, No.26 Qinglan Street,
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number884.5160
Classification Product Code
Date Received04/29/2020
Decision Date 05/04/2021
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