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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 K964403
Device Name SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
Applicant
THE FIRST YEARS, INC.
ONE KIDDIE DR.
AVON,  MA  02322
Applicant Contact ANTHONY PAOLO
Correspondent
THE FIRST YEARS, INC.
ONE KIDDIE DR.
AVON,  MA  02322
Correspondent Contact ANTHONY PAOLO
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/04/1996
Decision Date 01/13/1997
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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