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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 K230481
Device Name Evenflo Premium Double Electric Breast Pump (Model 4018)
Applicant
Evenflo Feeding, Inc.
9277 Centre Pointe Dr.
Suite 160
West Chester,  OH  45069
Applicant Contact Michael Sewak
Correspondent
Evenflo Feeding, Inc.
9277 Centre Pointe Dr.
Suite 160
West Chester,  OH  45069
Correspondent Contact Michael Sewak
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/22/2023
Decision Date 11/03/2023
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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