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FDA 510(k) Application Details - K133742
Device Classification Name
Accessory, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K133742
Device Name
Accessory, Assisted Reproduction
Applicant
AT MEDICAL UAB
DRAUGYSTES G.19
KAUNAS 51230 LT
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Contact
THOMAS PEDERSEN
Other 510(k) Applications for this Contact
Regulation Number
884.6120
More FDA Info for this Regulation Number
Classification Product Code
MQG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2013
Decision Date
04/23/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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