K112131 is an FDA 510(k) clearance for the NEODYNE DRESSING, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Neodyne Biosciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on September 29, 2011, 65 days after receiving the submission on July 26, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K112131 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 26, 2011 |
| Decision Date | September 29, 2011 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MDA — Elastomer, Silicone, For Scar Management |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4025 |