510(k) K151087

CS 8100SC, CS8100SC Access by Trophy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2015
Date Received
April 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type