FDA 510(k) Application Details - K003375

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K003375
Device Name	Condom With Nonoxynol-9
Applicant	TECNILATEX S.A. APDO. CORREOS, 156 C/FRAGUAS, 2 ALCORCON MADRID 28923 ES Other 510(k) Applications for this Company
Contact	JOSE M VAZQUEZ MARTIN 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	10/30/2000
Decision Date	01/28/2001
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