510(k) K961802
- Device
- PRECLUDE SYNBLOC MEMBRANE
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K961802
- Product code
- GXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-31
- Date received
- 1996-05-09
- 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
- JOHN W NICHOLSON
- Address
- 301 Airport Rd. Elkton MD US 21922 21922
Source Documents#
Other 510(k) Records For Product Code GXO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 | Codman & Shurtleff, Inc. | 2004-02-25 |
Legacy Summary#
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FDA Review#
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