The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Craniofacial Implants With Embedded Titanium Mesh.
| Device ID | K040364 |
| 510k Number | K040364 |
| Device Name: | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH |
| Classification | Mesh, Surgical |
| 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 | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613252204442 | K040364 | 000 |
| 07613252084303 | K040364 | 000 |
| 07613252084297 | K040364 | 000 |
| 07613252084280 | K040364 | 000 |
| 07613252084273 | K040364 | 000 |
| 07613252084266 | K040364 | 000 |
| 07613252084259 | K040364 | 000 |
| 07613252084242 | K040364 | 000 |
| 07613252084235 | K040364 | 000 |
| 07613252084228 | K040364 | 000 |
| 07613252084211 | K040364 | 000 |
| 07613252084310 | K040364 | 000 |
| 07613252084327 | K040364 | 000 |
| 07613252084341 | K040364 | 000 |
| 07613252204435 | K040364 | 000 |
| 07613252084815 | K040364 | 000 |
| 07613252084792 | K040364 | 000 |
| 07613252084785 | K040364 | 000 |
| 07613252084402 | K040364 | 000 |
| 07613252084396 | K040364 | 000 |
| 07613252084389 | K040364 | 000 |
| 07613252084372 | K040364 | 000 |
| 07613252084365 | K040364 | 000 |
| 07613252084358 | K040364 | 000 |
| 07613252084334 | K040364 | 000 |