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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 K262774
Device Name Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
Applicant
Guangdong Horigen Mother & Baby Products Co., Ltd.
# 18, Pingnan Industrial Zone, Mianbei St.
Chaoyang District
Shantou,  CN 515100
Applicant Contact Changxin Chen
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/04/2026
Decision Date 09/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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