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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 K200406
Device Name Evolve Breast Pump
Applicant
Hygeia II Medical Group, Inc.
6241 Yarrow Dr.
Carlsbad,  CA  92011
Applicant Contact Brett Nakfoor
Correspondent
Hygeia II Medical Group, Inc.
6241 Yarrow Dr.
Carlsbad,  CA  92011
Correspondent Contact Brett Nakfoor
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/19/2020
Decision Date 03/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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