510(k) K101177

APEXNRG RIDER by Medicnrg , Ltd. — Product Code LQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2010
Date Received
April 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Root Apex
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type