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510(k) K062857

KLS MARTIN QUICK DISC by KLS Martin L.P. — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2006
Date Received
September 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

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