K192674 is an FDA 510(k) clearance for the Mixing and Delivery System, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Bone Solutions, Inc. (Colleyville, US). The FDA issued a Cleared decision on February 18, 2020, 145 days after receiving the submission on September 26, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K192674 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2019 |
| Decision Date | February 18, 2020 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |