FDA 510(k) Application Details - K012969

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K012969
Device Name	Condom With Nonoxynol-9
Applicant	MEDTECH PRODUCTS LTD. S-59 20TH ST., ANNA NAGAR WEST CHENNAI 600 040 IN Other 510(k) Applications for this Company
Contact	A. V. K. REDDY Other 510(k) Applications for this Contact
Regulation Number	884.5310   More FDA Info for this Regulation Number
Classification Product Code	LTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/2001
Decision Date	06/12/2002
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