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510(k) K071791

MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 by Codman & Shurtleff, Inc. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
July 2, 2007
Clearance Type
Special
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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