Device Type ID | 3717 |
Device Name | Instrument, Cranioplasty Material Forming |
Regulation Description | Cranioplasty Material Forming Instrument. |
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) Exempt |
CFR Regulation Number | 882.4500 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HBX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3717 |
Device | Instrument, Cranioplasty Material Forming |
Product Code | HBX |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Cranioplasty Material Forming Instrument. |
CFR Regulation Number | 882.4500 [🔎] |