The following data is part of a premarket notification filed by Porex Surgical Products Group with the FDA for Medpor Pterional Surgical Implant.
| Device ID | K002586 |
| 510k Number | K002586 |
| Device Name: | MEDPOR PTERIONAL SURGICAL IMPLANT |
| Classification | Implant, Temporal |
| Applicant | POREX SURGICAL PRODUCTS GROUP 15 DART RD. Newnan, GA 30265 -1017 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL PRODUCTS GROUP 15 DART RD. Newnan, GA 30265 -1017 |
| Product Code | MNF |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252508670 | K002586 | 000 |
| 07613252508526 | K002586 | 000 |