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FDA 510(k) Application Details - K070047
Device Classification Name
Labware, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K070047
Device Name
Labware, Assisted Reproduction
Applicant
NUNC A/S
KAMSTRUPUEJ 90, KAMSTRUP
ROSKILDE DK-4000 DK
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Contact
JANA S HELLMANN
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
01/04/2007
Decision Date
05/18/2007
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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