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510(k) K110415

SIGNATURE PLANNER / SIGNATURE GUIDES by Materialise NV — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2011
Date Received
February 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

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