The following data is part of a premarket notification filed by Bone Solutions, Inc. with the FDA for Bone Solutions Mixing And Delivery System.
| Device ID | K161568 |
| 510k Number | K161568 |
| Device Name: | Bone Solutions Mixing And Delivery System |
| Classification | Syringe, Piston |
| Applicant | BONE SOLUTIONS, INC. 5712 COLLEYVILLE BLVD, SUITE 210 Colleyville, TX 76034 |
| Contact | Drew Diaz |
| Correspondent | Drew Diaz BONE SOLUTIONS, INC. 5712 COLLEYVILLE BLVD, SUITE 210 Colleyville, TX 76034 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-07 |
| Decision Date | 2016-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842528128787 | K161568 | 000 |
| 00842528128770 | K161568 | 000 |
| 00842528128756 | K161568 | 000 |