K060465 is an FDA 510(k) clearance for the PREMIO. This device is classified as a Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride) (Class II - Special Controls, product code MXW).
Submitted by Peters Surgical (Bobigny, FR). The FDA issued a Cleared decision on January 17, 2007, 329 days after receiving the submission on February 22, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K060465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2006 |
| Decision Date | January 17, 2007 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MXW - Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5010 |