Submission Details
| 510(k) Number | K041363 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2004 |
| Decision Date | July 27, 2004 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
K041363 is an FDA 510(k) clearance for the AOC BONE WAX, a Wax, Bone, submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on July 27, 2004, 67 days after receiving the submission on May 21, 2004. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K041363 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2004 |
| Decision Date | July 27, 2004 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MTJ — Wax, Bone |
| Device Class | — |