FDA 510(k) Application Details - K012544

Device Classification Name	Prosthesis, Tracheal, Expandable   More FDA Info for this Device
510(K) Number	K012544
Device Name	Prosthesis, Tracheal, Expandable
Applicant	VASCULAR ARCHITECTS, INC. 1830 BERING DR. SAN JOSE, CA 95112-4226 US Other 510(k) Applications for this Company
Contact	JEAN M CAILLOUETTE Other 510(k) Applications for this Contact
Regulation Number	878.3720   More FDA Info for this Regulation Number
Classification Product Code	JCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2001
Decision Date	11/15/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review