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510(k) K011619

PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT by Planmeca Oy — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2001
Date Received
May 25, 2001
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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