K060163 is an FDA 510(k) clearance for the CARDIOFLON, CARDIOXYL, a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II — Special Controls, product code GAT), submitted by Peters Surgical (Bobigny, FR). The FDA issued a Cleared decision on October 11, 2006, 261 days after receiving the submission on January 23, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K060163 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 2006 |
| Decision Date | October 11, 2006 |
| Days to Decision | 261 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT — Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5000 |