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510(k) K102018

NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY by Synthes USA Products, LLC — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2010
Date Received
July 19, 2010
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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