The following data is part of a premarket notification filed by Poriferous Llc with the FDA for Su-por Patient-specific Cranial Implant, Su-por Patient-specific Facial Implant.
| Device ID | K152463 |
| 510k Number | K152463 |
| Device Name: | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant |
| Classification | Prosthesis, Chin, Internal |
| Applicant | PORIFEROUS LLC 535 PINE ROAD, SUITE 206 Newnan, GA 30263 -7640 |
| Contact | Jerri L. Mann |
| Correspondent | Jerri L. Mann PORIFEROUS LLC 535 PINE ROAD, SUITE 206 Newnan, GA 30263 -7640 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-28 |
| Decision Date | 2016-01-20 |
| Summary: | summary |