FDA 510(k) Application Details - K974479

Device Classification Name	Stent, Vaginal   More FDA Info for this Device
510(K) Number	K974479
Device Name	Stent, Vaginal
Applicant	SILIMED, LLC. P.O BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E J SMITH Other 510(k) Applications for this Contact
Regulation Number	884.3900   More FDA Info for this Regulation Number
Classification Product Code	KXP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/1997
Decision Date	08/05/1998
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