| Device Type ID | 1601 |
| Device Name | Applicator, Ent Drug |
| Regulation Description | Ear, Nose, And Throat Drug Administration 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 | 510(K) Exempt |
| CFR Regulation Number | 874.5220 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LRD |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1601 |
| Device | Applicator, Ent Drug |
| Product Code | LRD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ear, Nose, And Throat Drug Administration Device. |
| CFR Regulation Number | 874.5220 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Summit Medical, Inc. | II | Dec-17-2015 |