Device Type ID | 3692 |
Device Name | Instrument, Dowel Cutting |
Regulation Description | Dowel Cutting 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) |
CFR Regulation Number | 882.4275 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | GZQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3692 |
Device | Instrument, Dowel Cutting |
Product Code | GZQ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Dowel Cutting Instrument. |
CFR Regulation Number | 882.4275 [🔎] |