FDA 510(k) Application Details - K151367

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K151367
Device Name	Media, Reproductive
Applicant	WILLIAM A. COOK AUSTRALIA PTY LTD 95 BRANDL STREET EIGHT MILE PLAINS 4113 AU Other 510(k) Applications for this Company
Contact	GORDANA POZVEK Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2015
Decision Date	01/27/2016
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