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510(k) K051642

FR.O.H. CALCANEUS REPAIR SYSTEM by I.T.S. Implantat-Technologie-Systeme GmbH — Product Code NDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
June 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone, Non-Spinal, Metallic
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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Other clearances for product code NDF

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