FDA 510(k) Application Details - K962433

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K962433
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 15 THORNTON RD. OAKLAND, NJ 07436 US Other 510(k) Applications for this Company
Contact	STEPHEN B ANDERSON 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	06/24/1996
Decision Date	03/17/1997
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