FDA 510(k) Application Details - K946207

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K946207
Device Name	Condom
Applicant	FRONTLINE LATEX PRODUCTS PVT. LTD. 57 WEST 38TH ST. 2ND FLOOR NEW YORK, NY 10018-5500 US Other 510(k) Applications for this Company
Contact	ASHEEM AGGARWAL 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	12/21/1994
Decision Date	01/24/1996
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