FDA 510(k) Application Details - K992958

Device Classification Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter   More FDA Info for this Device
510(K) Number	K992958
Device Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant	ATRIUM MEDICAL CORP. 5 WENTWORTH DR. HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	KAREN HALL 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	09/02/1999
Decision Date	10/01/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review