| Device Type ID | 3664 |
| Device Name | Strip, Craniosynostosis, Preformed |
| Regulation Description | Preformed Craniosynostosis Strip. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3664 |
| Device | Strip, Craniosynostosis, Preformed |
| Product Code | GXO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Craniosynostosis Strip. |
| CFR Regulation Number | 882.5900 [🔎] |