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510(k) K980581

PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM by Planmeca Oy — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1998
Date Received
February 17, 1998
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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