FDA 510(k) Application Details - K131355

Device Classification Name	More FDA Info for this Device
510(K) Number	K131355
Device Name	CONCEIVE PLUS
Applicant	SASMAR INC 155 NORTH WACKER DR, STE 4250 CHICAGO, IL 60606 US Other 510(k) Applications for this Company
Contact	JOHN-MICHAEL MANCINI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2013
Decision Date	11/07/2013
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