| Device Type ID | 1603 |
| Device Name | Dilator, Nasal |
| Regulation Description | Nasal Dilator. |
| 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 | 874.3900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LWF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1603 |
| Device | Dilator, Nasal |
| Product Code | LWF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nasal Dilator. |
| CFR Regulation Number | 874.3900 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 49 |
Failure To Obtain Sample | 10 |
Device Operates Differently Than Expected | 4 |
Inadequate Storage | 1 |
Invalid Sensing | 1 |
Missing Value Reason | 1 |
| Total Device Problems | 66 |