FDA 510(k) Application Details - K964877

Device Classification Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter   More FDA Info for this Device
510(K) Number	K964877
Device Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant	IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 TEMPE, AZ 85281 US Other 510(k) Applications for this Company
Contact	KRISTI M KISTNER Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1996
Decision Date	03/20/1997
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