FDA 510(k) Application Details - K972430

Device Classification Name	Condom With Nonoxynol-9   More FDA Info for this Device
510(K) Number	K972430
Device Name	Condom With Nonoxynol-9
Applicant	CUSTOM SERVICES INTL., INC. 3111 WEST POST RD. LAS VEGAS, NV 89118 US Other 510(k) Applications for this Company
Contact	LILLIE C THOMAS 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	06/27/1997
Decision Date	09/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review