FDA 510(k) Application Details - K102600

Device Classification Name Pump, Breast, Powered

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510(K) Number K102600
Device Name Pump, Breast, Powered
Applicant EVENFLO COMPANY, INC.
225 BYERS RD.
MIAMISBURG, OH 45342 US
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Contact AMY NEFF
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 09/10/2010
Decision Date 12/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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