Product code ESH
- Device name
- Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3620
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771615 | AUDI-SIL EARMOLD MATERIAL | Coe Laboratories, Inc. | 1977-08-30 |