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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 K252583
Device Name Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
Applicant
A Cute Baby, Inc.
865 N 1430 W
Orem,  UT  84057
Applicant Contact Matthew Kho
Correspondent
A Cute Baby, Inc.
865 N 1430 W
Orem,  UT  84057
Correspondent Contact Matthew Kho
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/15/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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