The following data is part of a premarket notification filed by Bone Solutions, Inc. with the FDA for Mixing And Delivery System.
| Device ID | K192674 |
| 510k Number | K192674 |
| Device Name: | Mixing And Delivery System |
| Classification | Syringe, Piston |
| Applicant | Bone Solutions, Inc. 5712 Colleyville Blvd, STE 210 Colleyville, TX 76034 |
| Contact | Drew Diaz |
| Correspondent | Karen E Warden BackRoads Consulting PO BOX 566 Chesterland, OH 44026 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-02-18 |