The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Fortoss-cema.
| Device ID | K993238 |
| 510k Number | K993238 |
| Device Name: | FORTOSS-CEMA |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIOCOMPOSITES LTD. ETRUSCAN ST., ETRURIA Stoke On Trent, GB St1 5pq |
| Contact | Js Bratt |
| Correspondent | Js Bratt BIOCOMPOSITES LTD. ETRUSCAN ST., ETRURIA Stoke On Trent, GB St1 5pq |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 2000-01-14 |
| Summary: | summary |