The following data is part of a premarket notification filed by Poriferous, Llc. with the FDA for Su-por Surgical Implant.
| Device ID | K140437 |
| 510k Number | K140437 |
| Device Name: | SU-POR SURGICAL IMPLANT |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | PORIFEROUS, LLC. 535 PINE ROAD, SUITE 206 Newnan, GA 30263 |
| Contact | Aaron Noble |
| Correspondent | Aaron Noble PORIFEROUS, LLC. 535 PINE ROAD, SUITE 206 Newnan, GA 30263 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-06-13 |
| Summary: | summary |