FDA 510(k) Application Details - K061626

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K061626
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	SUNWEI TECH CO. LTD. 7128 STAFFORDSHIRE STREET HOUSTON, TX 77030 US Other 510(k) Applications for this Company
Contact	JOSEPH J CHANG Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2006
Decision Date	10/05/2006
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