FDA 510(k) Application Details - K132490

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K132490
Device Name	Condom
Applicant	TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L 2871, COASTAL DR AURORA, IL 60503 US Other 510(k) Applications for this Company
Contact	MANOJ ZACHARIAS 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	08/08/2013
Decision Date	10/20/2014
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