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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 K190465
Device Name Evolve Breast Pump
Applicant
Hygeia II Medical Group, Inc.
6241 Yarrow Drive
carlsbad,  CA  92011
Applicant Contact brett nakfoor
Correspondent
Hygeia II Medical Group, Inc.
6241 Yarrow Drive
carlsbad,  CA  92011
Correspondent Contact brett nakfoor
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/26/2019
Decision Date 10/18/2019
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
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