Device Type ID | 3833 |
Device Name | Laser, Neurosurgical |
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 | Contact ODE |
FDA Device Classification | Class 3 Medical Device |
Product Code | LKW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3833 |
Device | Laser, Neurosurgical |
Product Code | LKW |
FDA Device Classification | Class 3 Medical Device |