Device Type ID | 2523 |
Device Name | Set, Oral Administration |
Regulation Description | Gastrointestinal Tube And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
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 | 510(k) |
CFR Regulation Number | 876.5980 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | LEY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2523 |
Device | Set, Oral Administration |
Product Code | LEY |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Gastrointestinal Tube And Accessories. |
CFR Regulation Number | 876.5980 [🔎] |