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510(k) K123419

EVA SELECT DIGITAL DENTAL IMAGING SYSTEM by Afp Imaging Corp. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2012
Date Received
November 6, 2012
Clearance Type
Special
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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  • K930761 — IMAGE-X 70 INTRAORAL X-RAY SYSTEM (May 25, 1993)
  • K925684 — OLYMP-X,X-RAY GENERATOR (February 2, 1993)

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