FDA 510(k) Application Details - K000737

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K000737
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	XENTEK MEDICAL, INC. 6136 FM 1616 ATHENS, TX 75751 US Other 510(k) Applications for this Company
Contact	JIM EDDINGS Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2000
Decision Date	08/01/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review