| Device Type ID | 5448 |
| Device Name | Elastomer, Silicone Block |
| Regulation Description | Ear, Nose, And Throat Synthetic Polymer Material. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MIB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5448 |
| Device | Elastomer, Silicone Block |
| Product Code | MIB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ear, Nose, And Throat Synthetic Polymer Material. |
| CFR Regulation Number | 874.3620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTERNATIONAL MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Damaged Prior To Use | 1 |
Break | 1 |
| Total Device Problems | 4 |