FDA 510(k) Application Details - K113686

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K113686
Device Name	Condom
Applicant	MAYER LABORATORIES, INC. 1950 ADDISON STREET, SUITE 101 BERKELY, CA 94704-1182 US Other 510(k) Applications for this Company
Contact	DAVID P MAYER Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2011
Decision Date	03/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review