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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 K233136
Device Name Hygeia Express Powered Breast Pump
Applicant
Hygeia II Medical Group, Inc.
6241 Yarrow Dr.
Suite A
Carlsbad,  CA  92011
Applicant Contact Brett Nakfoor
Correspondent
Hygeia II Medical Group, Inc.
6241 Yarrow Dr.
Suite A
Carlsbad,  CA  92011
Correspondent Contact Brett Nakfoor
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/27/2023
Decision Date 03/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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