FDA 510(k) Application Details - K090259

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K090259
Device Name	Condom
Applicant	OKAMOTO U.S.A., INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	JEFFERY N GIBBS 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	02/02/2009
Decision Date	03/31/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review