FDA 510(k) Application Details - K110282

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K110282
Device Name	Set, Administration, Intravascular
Applicant	MEDX-SET LTD 56B SHAWDOW DR. HUDSON, NH 03051 US Other 510(k) Applications for this Company
Contact	RAYMOND KELLY Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2011
Decision Date	04/27/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review