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
FDA 510(k) K033395 · Codman & Shurtleff, Inc.
510(k) numberK033395
Submission
- Device name
- 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.
Raynham, MA, US - Received
- October 23, 2003
- Decision date
- February 25, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961802 | Preclude Synbloc MembraneGXO · Traditional | W. L. Gore & Associates, Inc. | 07/31/1996SE |
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| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was 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 cleared by the FDA?
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 (K033395) received a 510(k) decision of Substantially Equivalent on February 25, 2004, 125 days after the submission was received.
What is the product code of K033395?
The FDA product code is GXO – Strip, Craniosynostosis, Preformed, a Class II (moderate risk) device regulated under 21 CFR 882.5900.