FDA 510(k) Application Details - K142207

Device Classification Name Micromanipulators And Microinjectors, Assisted Reproduction

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510(K) Number K142207
Device Name Micromanipulators And Microinjectors, Assisted Reproduction
Applicant EPPENDORF AG
BARKHANSENWEG 1
HAMBURG 22339 DE
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Contact CORNELIA HILDEBRANDT
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Regulation Number 884.6150

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Classification Product Code MQJ
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Date Received 08/11/2014
Decision Date 01/23/2015
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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