510(k) K112512

VANISHPOINT BLOOD COLLECTION SET by Retractable Technologies, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2011
Date Received
August 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type