FDA 510(k) Application Details - K013086

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K013086
Device Name	Condom
Applicant	TRIGG LABORATORIES, INC. WARNER CENTER PLAZA 21800 OXNARD STREET, SUITE 840 WOODLAND HILLS, CA 91367 US Other 510(k) Applications for this Company
Contact	W. PATRICK NOONAN 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	09/14/2001
Decision Date	12/13/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review