FDA 510(k) Application Details - K142479

Device Classification Name Pump, Breast, Powered

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510(K) Number K142479
Device Name Pump, Breast, Powered
Applicant WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT
WUXI CITY 214000 CN
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Contact ANNE CHEN
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 09/04/2014
Decision Date 02/24/2015
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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