510(k) K113600

IM BAND by Synexmed(Shenzhen)Company Limited — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2012
Date Received
December 5, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type