Device Type ID | 3743 |
Device Name | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
Regulation Description | Methyl Methacrylate For Cranioplasty. |
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 | 882.5300 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MYU |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3743 |
Device | Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty |
Product Code | MYU |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Methyl Methacrylate For Cranioplasty. |
CFR Regulation Number | 882.5300 [🔎] |