FDA 510(k) Application Details - K974324

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K974324
Device Name	Condom With Nonoxynol-9
Applicant	REDDY MEDTECH HEALTH PRODUCTS LTD. 9 WEBSTER COURT PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	RAVI 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	11/18/1997
Decision Date	02/09/1998
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