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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 K032566
Device Name NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP
Applicant
THE FIRST YEARS, INC.
ONE KIDDIE DR.
AVON,  MA  02322
Applicant Contact ROBIN C CONNOR
Correspondent
THE FIRST YEARS, INC.
ONE KIDDIE DR.
AVON,  MA  02322
Correspondent Contact ROBIN C CONNOR
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/21/2003
Decision Date 09/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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