FDA 510(k) Application Details - K203383

Device Classification Name Pump, Breast, Powered

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510(K) Number K203383
Device Name Pump, Breast, Powered
Applicant Philips Consumer Lifestyle - Innovation Site Eindhoven
High Tech Campus 37
Eindhoven 5656 AE NL
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Contact Aurore Millet
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 11/17/2020
Decision Date 12/15/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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