The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Surgical Implant Material.
| Device ID | K943275 |
| 510k Number | K943275 |
| Device Name: | MEDPOR SURGICAL IMPLANT MATERIAL |
| Classification | Implant, Eye Sphere |
| Applicant | POREX SURGICAL, INC. 500 BOHANNON RD. Fairburn, GA 30213 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL, INC. 500 BOHANNON RD. Fairburn, GA 30213 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-09-02 |