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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 K101157
Device Name E-BASIC SINGLE BREAST PUMP
Applicant
MAPA GMBH
2081 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Applicant Contact SHEILA W PICKERING
Correspondent
MAPA GMBH
2081 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Correspondent Contact SHEILA W PICKERING
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/26/2010
Decision Date 09/17/2010
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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