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FDA 510(k) Application Details - K130349
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K130349
Device Name
Pump, Breast, Powered
Applicant
DAO HEALTH
1345 EASY LN. EL DORADO HILLS
CALIFORNIA, CA 95762 US
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Contact
DAN GARBEZ
Other 510(k) Applications for this Contact
Regulation Number
884.5160
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Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
02/12/2013
Decision Date
09/06/2013
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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