510(k) K080113

APEX DAL ELECTRONIC APEX LOCATOR by Medicnrg , Ltd. — Product Code LQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2008
Date Received
January 16, 2008
Clearance Type
Special
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