Definition: Call For PMAs On 7/13/99 Per 64 FR 18329 On 4/14/99
Device Type ID | 1474 |
Device Name | Device, Antichoke, Suction |
Regulation Description | Suction Antichoke Device. |
Regulation Medical Specialty | Ear Nose & Throat |
Review Panel | Ear Nose & Throat |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
Submission Type | PMA |
CFR Regulation Number | 874.5350 [🔎] |
FDA Device Classification | Class 3 Medical Device |
Product Code | EWT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 1474 |
Device | Device, Antichoke, Suction |
Product Code | EWT |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Suction Antichoke Device. |
CFR Regulation Number | 874.5350 [🔎] |