FDA 510(k) Application Details - K983045

Device Classification Name	Stent, Vaginal   More FDA Info for this Device
510(K) Number	K983045
Device Name	Stent, Vaginal
Applicant	Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	ROBERT E SHAW 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	09/01/1998
Decision Date	11/25/1998
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