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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 K110343
Device Name TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
Applicant
MAYBORN BABY AND CHILD / JACKEL INTERNATIONAL LTD
NORTHUMBERLAND BUSINESS PARK W
CRAMLINGTON, NORTHUMBERLAND,  GB NE23 7RH
Applicant Contact NEIL HEWITT
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/04/2011
Decision Date 03/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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