FDA 510(k) Application Details - K063227

Device Classification Name	Kit, Conception-Assist, Home Use   More FDA Info for this Device
510(K) Number	K063227
Device Name	Kit, Conception-Assist, Home Use
Applicant	CONCEIVEX INC. 2600 MULLINIX MILL ROAD MT. AIRY, MD 21771 US Other 510(k) Applications for this Company
Contact	BLIX WINSTON 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	10/24/2006
Decision Date	03/14/2007
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