The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Stimulan Kit, Stimulan Rapid Cure.
| Device ID | K141830 |
| 510k Number | K141830 |
| Device Name: | STIMULAN KIT, STIMULAN RAPID CURE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Contact | Marie Whalley |
| 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 | 2014-07-07 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50601557110416 | K141830 | 000 |
| 15060155711543 | K141830 | 000 |
| 15060155711550 | K141830 | 000 |
| 15060155711567 | K141830 | 000 |
| 15060155711574 | K141830 | 000 |
| 50601557101124 | K141830 | 000 |
| 50601557101292 | K141830 | 000 |
| 50601557110270 | K141830 | 000 |
| 50601557110348 | K141830 | 000 |
| 15060155711536 | K141830 | 000 |