510(k) K092917

STERN'S S250 NORDAM by Cefla S.C. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2010
Date Received
September 22, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type