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FDA 510(k) Application Details - K141365
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K141365
Device Name
Needle, Assisted Reproduction
Applicant
WILLIAM A. COOK AUSTRALIA PTY, LTD.
95 BRANDL ST
EIGHT MILE PLAINS, QUEENSLAND 4113 AU
Other 510(k) Applications for this Company
Contact
KATIE-LOU BUSCHER
Other 510(k) Applications for this Contact
Regulation Number
884.6100
More FDA Info for this Regulation Number
Classification Product Code
MQE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2014
Decision Date
08/07/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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