K002488 is an FDA 510(k) clearance for the KELO-COTE TOPICAL GEL, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Advanced Bio-Technologies, Inc. (Cranage, Cheshire, GB). The FDA issued a Cleared decision on January 5, 2001, 144 days after receiving the submission on August 14, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K002488 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 2000 |
| Decision Date | January 05, 2001 |
| Days to Decision | 144 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 |