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FDA 510(k) Application Details - K131145
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K131145
Device Name
Labware, Assisted Reproduction
Applicant
NIDACON INTERNATIONAL AB
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact
DANIEL KAMM
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
04/23/2013
Decision Date
02/20/2014
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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