510(k) K033395
- Device
- 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
- Applicant
- Codman & Shurtleff, Inc.
- 510(k) number
- K033395
- Product code
- GXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-02-25
- Date received
- 2003-10-23
- Regulation
- 882.5900
- Classification name
- Strip, Craniosynostosis, Preformed
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LIZ DOLAN
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
Source Documents#
Other 510(k) Records For Product Code GXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961802 | PRECLUDE SYNBLOC MEMBRANE | W. L. Gore & Associates, Inc. | 1996-07-31 |
Legacy Summary#
summary
FDA Review#
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