Device Type ID | 907 |
Device Name | Actuator, Syringe, For Injector, Reprocessed |
Regulation Description | Syringe Actuator For An Injector. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.1670 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NKW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 907 |
Device | Actuator, Syringe, For Injector, Reprocessed |
Product Code | NKW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Syringe Actuator For An Injector. |
CFR Regulation Number | 870.1670 [🔎] |