The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Customized Surgical Implant.
| Device ID | K083621 |
| 510k Number | K083621 |
| Device Name: | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Classification | Polymer, Ent Synthetic, Porous Polyethylene |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Jerri L Mann |
| Correspondent | Jerri L Mann POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | JOF |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-02-03 |
| Summary: | summary |