FDA 510(k) Application Details - K111411

Device Classification Name Pump, Breast, Powered

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510(K) Number K111411
Device Name Pump, Breast, Powered
Applicant DAO HEALTH
2526 Capitol Avenue
Sacramento, CA 95816 US
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Contact DAN GARBEZ
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 05/20/2011
Decision Date 02/01/2012
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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