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510(k) K192394

Hi-Fatigue Bone Cement by Osartis GmbH — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2019
Date Received
September 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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