Submission Details
| 510(k) Number | K924223 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1992 |
| Decision Date | March 18, 1993 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
K924223 is an FDA 510(k) clearance for the MAR-MED LIVER STRAP, a Clamp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDJ), submitted by Mar-Med Co. (Grand Rapids, US). The FDA issued a Cleared decision on March 18, 1993, 209 days after receiving the submission on August 21, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K924223 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1992 |
| Decision Date | March 18, 1993 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDJ — Clamp, Surgical, General & Plastic Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |