The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Stimulan -calcium Sulfate Bone Void Filter.
| Device ID | K001724 |
| 510k Number | K001724 |
| Device Name: | STIMULAN -CALCIUM SULFATE BONE VOID FILTER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOCOMPOSITES LTD. ETRUSCAN ST. ETRURIA Stoke On Trent, Staffordshire, GB St1 5pq |
| Contact | Stephen Bratt |
| Correspondent | 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 | 2000-06-06 |
| Decision Date | 2000-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50601557100998 | K001724 | 000 |
| 50601557100752 | K001724 | 000 |
| 50601557100516 | K001724 | 000 |