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510(k) K180360

OKTAGON Implant System by Hager& Meisinger GmbH — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2018
Date Received
February 9, 2018
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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