The following data is part of a premarket notification filed by Oxford Performance Materials with the FDA for Osteofab Patient Specific Facial Device.
| Device ID | K133809 |
| 510k Number | K133809 |
| Device Name: | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | OXFORD PERFORMANCE MATERIALS 30 South Satellite Road South Windsor, CT 06074 |
| Contact | Leigh Ayres |
| Correspondent | Leigh Ayres OXFORD PERFORMANCE MATERIALS 30 South Satellite Road South Windsor, CT 06074 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-07-28 |
| Summary: | summary |