FDA 510(k) Application Details - K964665

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K964665
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	CARBOMEDICS, INC. 1300 EAST ANDERSON LN. AUSTIN, TX 78752-1793 US Other 510(k) Applications for this Company
Contact	TEENA M AUGOSTINO 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	11/21/1996
Decision Date	02/19/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review