The following data is part of a premarket notification filed by Porex Medical with the FDA for Porex(tm) Ear Prosthesis.
| Device ID | K863939 |
| 510k Number | K863939 |
| Device Name: | POREX(TM) EAR PROSTHESIS |
| Classification | Prosthesis, Ear, Internal |
| Applicant | POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
| Contact | Howard A Mercer,phd |
| Correspondent | Howard A Mercer,phd POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
| Product Code | FZD |
| CFR Regulation Number | 878.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-10 |
| Decision Date | 1986-10-24 |