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FDA 510(k) Application Details - K192146
Device Classification Name
Microtools, Assisted Reproduction (Pipettes)
More FDA Info for this Device
510(K) Number
K192146
Device Name
Microtools, Assisted Reproduction (Pipettes)
Applicant
Vitromed GmbH
Hans-Kn÷ll-Str. 6
Jena 07745 DE
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Contact
Deepesh Changat
Other 510(k) Applications for this Contact
Regulation Number
884.6130
More FDA Info for this Regulation Number
Classification Product Code
MQH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2019
Decision Date
01/28/2020
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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