K082491 is an FDA 510(k) clearance for the OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE, a Wax, Bone, submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 24, 2008, 27 days after receiving the submission on August 28, 2008. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K082491 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 28, 2008 |
| Decision Date | September 24, 2008 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |