The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Allogran-r.
| Device ID | K061311 |
| 510k Number | K061311 |
| Device Name: | ALLOGRAN-R |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50601557100448 | K061311 | 000 |
| 50601557100370 | K061311 | 000 |
| 50601557100202 | K061311 | 000 |