K053481 is an FDA 510(k) clearance for the KELO-COTE SPRAY, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Advanced Bio-Technologies, Inc. (Redmond, US). The FDA issued a Cleared decision on April 14, 2006, 121 days after receiving the submission on December 14, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K053481 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 14, 2005 |
| Decision Date | April 14, 2006 |
| Days to Decision | 121 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 |