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FDA 510(k) Application Details - K142207
Device Classification Name
Micromanipulators And Microinjectors, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K142207
Device Name
Micromanipulators And Microinjectors, Assisted Reproduction
Applicant
EPPENDORF AG
BARKHANSENWEG 1
HAMBURG 22339 DE
Other 510(k) Applications for this Company
Contact
CORNELIA HILDEBRANDT
Other 510(k) Applications for this Contact
Regulation Number
884.6150
More FDA Info for this Regulation Number
Classification Product Code
MQJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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