The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Genex Bone Graft Substitute.
| Device ID | K040600 |
| 510k Number | K040600 |
| Device Name: | GENEX BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOCOMPOSITES LTD. ETRUSCAN ST. ETRURIA Stoke On Trent, Staffordshire, GB St1 5pq |
| Contact | J. Stephen Bratt |
| Correspondent | J. Stephen Bratt BIOCOMPOSITES LTD. ETRUSCAN ST. ETRURIA Stoke On Trent, Staffordshire, GB St1 5pq |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-05-07 |
| Summary: | summary |