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510(k) K931001

ORALIX DC by Gendex Corp. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1993
Date Received
February 26, 1993
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

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  • K890083 — GX-2000 STATIONARY X-RAY GENERATOR (March 31, 1989)
  • K873982 — GX-MOBILE X-RAY UNIT (October 30, 1987)

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