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FDA 510(k) Application Details - K121478
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K121478
Device Name
Pump, Breast, Powered
Applicant
MAPA GMBH
728 BOOSTER BLVD.
REEDSBURG, WI 53959 US
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Contact
MARK WOZNIAK
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2012
Decision Date
04/05/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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