FDA 510(k) Application Details - K100984

Device Classification Name	Vessel Guard Or Cover   More FDA Info for this Device
510(K) Number	K100984
Device Name	Vessel Guard Or Cover
Applicant	XYLOS CORPORATION 838 TOWN CENTER DR. LANGHORNE, PA 19047 US Other 510(k) Applications for this Company
Contact	JOYCE ELKINS Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	OMR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2010
Decision Date	07/07/2010
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review