The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Nangel.
| Device ID | K083005 |
| 510k Number | K083005 |
| Device Name: | NANGEL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Roundrock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb TEKNIMED SA 1001 OAKWOOD BLVD Roundrock, TX 78681 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-08 |
| Decision Date | 2009-03-04 |