FDA 510(k) Application Details - K964197

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K964197
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 TEMPE, AZ 85281 US Other 510(k) Applications for this Company
Contact	RAJAGOPAL KOWLIGI 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	10/21/1996
Decision Date	01/02/1997
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