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 |