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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, Non-Powered
510(k) Number K032845
Device Name EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
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 Number884.5150
Classification Product Code
HGY  
Date Received09/11/2003
Decision Date 04/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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