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