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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 K230776
Device Name Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
Applicant
Shenzhen Lutejiacheng Technology Co., Ltd.
#2-2, Floor 2 Hasee Computer Bldg., #2 Beier Rd.,
Bantian St., Longgang
Shenzhen,  CN 518129
Applicant Contact Athena Pan
Correspondent
Shenzhen Lutejiacheng Technology Co., Ltd.
#2-2, Floor 2 Hasee Computer Bldg., #2 Beier Rd.,
Bantian St., Longgang
Shenzhen,  CN 518129
Correspondent Contact Athena Pan
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/21/2023
Decision Date 06/09/2023
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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