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510(k) K073435

KODAK 9000, KODAK 9000 3D by Trophy — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2008
Date Received
December 6, 2007
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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  • K133406 — CS 8100 3D (March 14, 2014)
  • K120975 — CS 8100 CS 8100 ACCESS (June 22, 2012)
  • K113419 — CS IMAGING (February 16, 2012)

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