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510(k) K120975

CS 8100 CS 8100 ACCESS by Trophy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
April 2, 2012
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

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