The following data is part of a premarket notification filed by Porex Technologies Corp. Of Georgia with the FDA for Ossicular Prosthesis: 8 Partial, 3 Total.
| Device ID | K884884 |
| 510k Number | K884884 |
| Device Name: | OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL |
| Classification | Replacement, Ossicular Prosthesis, Total |
| Applicant | POREX TECHNOLOGIES CORP. OF GEORGIA 500 BOHANNON RD. Fairburn, GA 30213 |
| Contact | Howard A Mercer,phd |
| Correspondent | Howard A Mercer,phd POREX TECHNOLOGIES CORP. OF GEORGIA 500 BOHANNON RD. Fairburn, GA 30213 |
| Product Code | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-22 |
| Decision Date | 1989-06-16 |