K924571 is an FDA 510(k) clearance for the MEDI-SOL, a Solvent, Adhesive Tape (Class I — General Controls, product code KOX), submitted by Orange-Sol, Inc. (Gilbert, US). The FDA issued a Cleared decision on April 6, 1993, 208 days after receiving the submission on September 10, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4730.
| 510(k) Number | K924571 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 10, 1992 |
| Decision Date | April 06, 1993 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KOX — Solvent, Adhesive Tape |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4730 |