K142348 is an FDA 510(k) clearance for the OsteoSeal Bone Hemostat. This device is classified as a Wax, Bone.
Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on January 23, 2015, 154 days after receiving the submission on August 22, 2014.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K142348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2014 |
| Decision Date | January 23, 2015 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |