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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 K223693
Device Name Electric breast pump (model: M5)
Shenzhen Lutejiacheng Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Building, No.2 Beier Rd,
Bantian Street, Longgang
Shenzhen,  CN 518129
Applicant Contact Athena Pan
Shenzhen Reanny Medical Devices Management Consulting Co., L
Room 1407, Jingting Building, Dongzhou Community,
Guangming Street, Guangming District
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number884.5160
Classification Product Code
Date Received12/09/2022
Decision Date 03/09/2023
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