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510(k) K033395

CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 by Codman & Shurtleff, Inc. — Product Code GXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2004
Date Received
October 23, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Craniosynostosis, Preformed
Device Class
Class II
Regulation Number
882.5900
Review Panel
NE
Submission Type

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Other clearances for product code GXO

  • K961802 — PRECLUDE SYNBLOC MEMBRANE (July 31, 1996)