FDA 510(k) Application Details - K082782

Device Classification Name	Vessel Guard Or Cover   More FDA Info for this Device
510(K) Number	K082782
Device Name	Vessel Guard Or Cover
Applicant	REPLICATION MEDICAL INC 901 KING STREET SUITE 200 ALEXANDRIA, VA 22314 US Other 510(k) Applications for this Company
Contact	MARCOS VELEZ-DURAN 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	09/22/2008
Decision Date	04/02/2009
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