510(k) K132267

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2014
Date Received
July 22, 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