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FDA 510(k) Application Details - K162833
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K162833
Device Name
Labware, Assisted Reproduction
Applicant
ORIGIO A/S
KNARDRUPVEJ 2
MALOV 2760 DK
Other 510(k) Applications for this Company
Contact
ROAIDA JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
884.6160
More FDA Info for this Regulation Number
Classification Product Code
MQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2016
Decision Date
02/16/2017
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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