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510(k) K032307

CAP BONE SUBSTITUTE MATERIAL by Etex Corp. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2003
Date Received
July 25, 2003
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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  • K080329 — CAP PLUS, EQUIVABONE, CAP/DBM (April 28, 2008)
  • K063050 — CAP PLUS (November 19, 2007)

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