FDA 510(k) Application Details - K070749

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K070749
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	COOMBS MEDICAL DEVICE CONSULTING 1193 SHERMAN STREET ALAMEDA, CA 94501 US Other 510(k) Applications for this Company
Contact	CRAIG COOMBS 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	03/19/2007
Decision Date	10/24/2007
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