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FDA 510(k) Application Details - K142164
Device Classification Name
Cannula, Manipulator/Injector, Uterine
More FDA Info for this Device
510(K) Number
K142164
Device Name
Cannula, Manipulator/Injector, Uterine
Applicant
GYNETECH PTY. LTD.
229 MARVILLA CIRCLE
PACIFICA, CA 94044 US
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Contact
KEVIN MACDONALD
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LKF
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More FDA Info for this Product Code
Date Received
08/06/2014
Decision Date
12/17/2014
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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