The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Triha +.
| Device ID | K031826 |
| 510k Number | K031826 |
| Device Name: | TRIHA + |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-11-28 |
| Summary: | summary |