FDA 510(k) Application Details - K954848

Device Classification Name	Graft, Vascular, Synthetic/Biologic Composite   More FDA Info for this Device
510(K) Number	K954848
Device Name	Graft, Vascular, Synthetic/Biologic Composite
Applicant	MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. OAKLAND, NJ 07436 US Other 510(k) Applications for this Company
Contact	CAROLYN TAUBER Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	MAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1995
Decision Date	02/01/1996
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