K052953 is an FDA 510(k) clearance for the NUVANCE* FACIAL REJUVENATION SYSTEM. This device is classified as a Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride) (Class II - Special Controls, product code MXW).
Submitted by Ethicon, Inc. (Sommerville, US). The FDA issued a Cleared decision on March 6, 2006, 137 days after receiving the submission on October 20, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K052953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2005 |
| Decision Date | March 06, 2006 |
| Days to Decision | 137 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 |