| Device Type ID | 1503 | 
| Device Name | Knife, Myringotomy | 
| Regulation Description | Ear, Nose, And Throat Manual Surgical Instrument. | 
| 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 | 874.4420 [🔎] | 
| FDA Device Classification | Class 1 Medical Device | 
| Product Code | JYP | 
| GMP Exempt | No | 
| Summary MR | Eligible | 
| Implanted Device | No | 
| Life Support Device | No | 
| Third Party Review | Not Third Party Eligible | 
| Device Type ID | 1503 | 
| Device | Knife, Myringotomy | 
| Product Code | JYP | 
| FDA Device Classification | Class 1 Medical Device | 
| Regulation Description | Ear, Nose, And Throat Manual Surgical Instrument. | 
| CFR Regulation Number | 874.4420 [🔎] |