Device Type ID | 1573 |
Device Name | Blower, Powder, Ent |
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 | KCL |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1573 |
Device | Blower, Powder, Ent |
Product Code | KCL |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Ear, Nose, And Throat Drug Administration Device. |
CFR Regulation Number | 874.5220 [🔎] |