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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 K101538
Device Name HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
Applicant
PHILIPS ELECTRONICS UK LIMITED
PAMPISFORD ROAD
GREAT ABINGTON, CAMBRIDGE,  GB CB21 6AH
Applicant Contact DIANA KORDA HEWITT
Correspondent
PHILIPS ELECTRONICS UK LIMITED
PAMPISFORD ROAD
GREAT ABINGTON, CAMBRIDGE,  GB CB21 6AH
Correspondent Contact DIANA KORDA HEWITT
Regulation Number884.5150
Classification Product Code
HGY  
Date Received06/03/2010
Decision Date 11/05/2010
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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