510(k) K140875

OPTOSSOL COMPRESSION DEVICE SYSTEM by Genossis, LLC — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2014
Date Received
April 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type