FDA 510(k) Application Details - K122337

Device Classification Name	Device, Fertility Diagnostic, Proceptive   More FDA Info for this Device
510(K) Number	K122337
Device Name	Device, Fertility Diagnostic, Proceptive
Applicant	FERTILITY FOCUS LTD 717 LAKEGLEN DRIVE SUWANEE, GA 30024 US Other 510(k) Applications for this Company
Contact	PENNY NORTHCUTT Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2012
Decision Date	08/06/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review