510(k) K110355

VENX REVOLUTION by Venx, LLC — Product Code GAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2011
Date Received
February 7, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type