510(k) K132445

PIEZON 250 by E.M.S Electro Medical Systems S.A — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2013
Date Received
August 6, 2013
Clearance Type
Special
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