POREX(TM) EAR PROSTHESIS
Device Facts
| Record ID | K863939 |
|---|---|
| Device Name | POREX(TM) EAR PROSTHESIS |
| Applicant | Porex Medical |
| Product Code | FZD · General, Plastic Surgery |
| Decision Date | Oct 24, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3590 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
