| Device Type ID | 1391 |
| Device Name | Solution, Cold Sterilizing |
| Regulation Description | Liquid Chemical Sterilants/high Level Disinfectants. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6885 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LFE |
| 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 | 1391 |
| Device | Solution, Cold Sterilizing |
| Product Code | LFE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Liquid Chemical Sterilants/high Level Disinfectants. |
| CFR Regulation Number | 880.6885 [🔎] |