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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 K233880
Device Name Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2, Hasee Computer Bldg.,
#2 Beier Rd., Bantian St., Longgang
Shenzhen,  CN 518129
Applicant Contact Athena Pan
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1407, Jingting Bldg., Dongzhou Community,
Guangming St., Guangming
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/08/2023
Decision Date 03/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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