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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 K131153
FOIA Releasable 510(k) K131153
Device Name EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
Applicant
EVENFLO FEEDING INCORPORATED
9277 Centre Pointe Dr Ste 160
West Chester,  OH  45069
Applicant Contact WADE HALMA
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/24/2013
Decision Date 06/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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