FDA 510(k) Application Details - K111093

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K111093
Device Name	Condom
Applicant	MAPA GMBH INDUSTRIESTRASSE 21-25 ZEVEN 27404 DE Other 510(k) Applications for this Company
Contact	GERMAN FRANK 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	04/19/2011
Decision Date	06/03/2011
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	Y
Expedited Review