K193052 is an FDA 510(k) clearance for the HBP6 Settable, Resorbable Hemostatic Bone Paste, a Wax, Bone, submitted by Orthocon, Inc. (Irvington, US). The FDA issued a Cleared decision on March 27, 2020, 147 days after receiving the submission on November 1, 2019. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K193052 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2019 |
| Decision Date | March 27, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |