Device Type ID | 2854 |
Device Name | Device, Peritoneal Access, Subcutaneous, Implanted |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | Contact ODE |
FDA Device Classification | Class 3 Medical Device |
Product Code | LMQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2854 |
Device | Device, Peritoneal Access, Subcutaneous, Implanted |
Product Code | LMQ |
FDA Device Classification | Class 3 Medical Device |