FDA 510(k) Application Details - K172772

Device Classification Name Pump, Breast, Powered

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510(K) Number K172772
Device Name Pump, Breast, Powered
Applicant DAO Health
1345 Easy Lane
El Dorado Hills, CA 95762 US
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Contact Dave Paul
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 09/14/2017
Decision Date 10/13/2017
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 Y
Expedited Review



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