510(k) K113430

PROULTRA PIEZO ULTRASONIC by Satelec - Acteon Group — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2012
Date Received
November 21, 2011
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