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510(k) K974877

CRANEX TOME CEPH, OR CRANEX TOME by Orion Corporation Soredex — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1998
Date Received
December 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Orion Corporation Soredex

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  • K934949 — DIGORA (February 10, 1994)
  • K880982 — ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY (June 6, 1988)

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