510(k) K001712

3D ACTIVETRAC by The Saunders Group — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2000
Date Received
June 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type