The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Plus Surgical Implant Biomaterial.
| Device ID | K012350 |
| 510k Number | K012350 |
| Device Name: | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL |
| Classification | Prosthesis, Chin, Internal |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-25 |
| Decision Date | 2002-03-14 |
| Summary: | summary |