Home / 510(k) Clearances / K983009

510(k) K983009

BSM- BONE SUBSTITUTE MATERIAL by Etex Corp. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
August 28, 1998
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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