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510(k) K051093

OSTEOPORE PCL SCAFFOLD by Osteopore, Inc. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2006
Date Received
April 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

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