FDA 510(k) Application Details - K162870

Device Classification Name Pump, Breast, Powered

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510(K) Number K162870
Device Name Pump, Breast, Powered
Applicant CIMILRE CO., LTD.
#201, 202, Sagimakgol-ro 148, Jungwon-gu
Seongnam-si 13207 KR
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Contact Ko Bong Jae
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Regulation Number 884.5160

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Classification Product Code HGX
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Date Received 10/13/2016
Decision Date 03/07/2017
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 N
Expedited Review



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