Device Type ID | 1128 |
Device Name | Unit, Suction Operatory |
Regulation Description | Dental Operative Unit And Accessories. |
Regulation Medical Specialty | Dental |
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) Exempt |
CFR Regulation Number | 872.6640 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | EBR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 1128 |
Device | Unit, Suction Operatory |
Product Code | EBR |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Dental Operative Unit And Accessories. |
CFR Regulation Number | 872.6640 [🔎] |