K031443 is an FDA 510(k) clearance for the LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Lsi Solutions (Victor, US). The FDA issued a Cleared decision on June 18, 2003, 43 days after receiving the submission on May 6, 2003.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K031443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2003 |
| Decision Date | June 18, 2003 |
| Days to Decision | 43 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW - Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4840 |