FDA 510(k) Application Details - K991047

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K991047
Device Name	Condom With Nonoxynol-9
Applicant	HARDCOVER PRODUCTS, INC. 55 ADMINISTRATION RD., UNIT 12 CONCORD, ONTARIO L4K 4G9 CA Other 510(k) Applications for this Company
Contact	GERRY PERSON 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	03/30/1999
Decision Date	06/18/1999
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