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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 K100435
Device Name AMEDA PLATINUM BREAST PUMP
Applicant
EVENFLO COMPANY, INC.
225 BYERS RD.
MIAMISBURG,  OH  45342
Applicant Contact STEVE NOWAK
Correspondent
EVENFLO COMPANY, INC.
225 BYERS RD.
MIAMISBURG,  OH  45342
Correspondent Contact STEVE NOWAK
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/16/2010
Decision Date 05/28/2010
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
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