FDA 510(k) Application Details - K161065

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K161065
Device Name	Culdoscope (And Accessories)
Applicant	Surgitools Pty Ltd. 231 Timberlane Dr. Woodvale 6026 AU Other 510(k) Applications for this Company
Contact	Jai Singh Other 510(k) Applications for this Contact
Regulation Number	884.1640   More FDA Info for this Regulation Number
Classification Product Code	HEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2016
Decision Date	10/27/2016
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