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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 K081463
Device Name MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
Applicant
MEDEL S.P.A.
112 CAVISTION WAY
CARY,  NC  27519
Applicant Contact TERRENCE O'BRIEN
Correspondent
MEDEL S.P.A.
112 CAVISTION WAY
CARY,  NC  27519
Correspondent Contact TERRENCE O'BRIEN
Regulation Number884.5160
Classification Product Code
HGX  
Date Received05/23/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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