FDA 510(k) Application Details - K140186

Device Classification Name	Kit, Conception-Assist, Home Use   More FDA Info for this Device
510(K) Number	K140186
Device Name	Kit, Conception-Assist, Home Use
Applicant	RINOVUM WOMEN'S HEALTH, INC 300 Oxford Dr Suite 330 Monroeville, PA 15146 US Other 510(k) Applications for this Company
Contact	ANDREW ZELTWANGER Other 510(k) Applications for this Contact
Regulation Number	884.5250   More FDA Info for this Regulation Number
Classification Product Code	OBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2014
Decision Date	07/11/2014
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