K973572 is an FDA 510(k) clearance for the KELOCOTE SCAR GEL AND KELOCOTE LASER GEL, a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA), submitted by Hanson Medical, Inc. (Kingston, US). The FDA issued a Cleared decision on October 21, 1997, 32 days after receiving the submission on September 19, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4025.
| 510(k) Number | K973572 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 1997 |
| Decision Date | October 21, 1997 |
| Days to Decision | 32 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 |