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510(k) K050478

MEDICON IMF-ORION SCREWS by Medicon EG — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2005
Date Received
February 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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