FDA 510(k) Application Details - K093551

Device Classification Name	Vessel Guard Or Cover   More FDA Info for this Device
510(K) Number	K093551
Device Name	Vessel Guard Or Cover
Applicant	SPINEMEDICA, LLC 811 LIVINGSTON COURT SUITE B MARIETTA, GA 30067 US Other 510(k) Applications for this Company
Contact	SALLY THORSEN 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	11/17/2009
Decision Date	12/24/2009
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review