510(k) K132322

NEWTRON P5 XS B.LED by Satelec - Acteon Group — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2014
Date Received
July 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type