FDA 510(k) Application Details - K082529

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K082529
Device Name	Condom
Applicant	ALATECH HEALTHCARE, LLC. 1600 STATE DOCKS RD. EUFAULA, AL 36027 US Other 510(k) Applications for this Company
Contact	NEIL ANDERSON 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	09/02/2008
Decision Date	05/01/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review