The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Nuvance* Facial Rejuvenation System.
| Device ID | K052953 |
| 510k Number | K052953 |
| Device Name: | NUVANCE* FACIAL REJUVENATION SYSTEM |
| Classification | Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride) |
| Applicant | ETHICON, INC. RT. 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
| Contact | Jennifer M Paine |
| Correspondent | Jennifer M Paine ETHICON, INC. RT. 22 WEST P.O. BOX 151 Somerville, NJ 08876 |
| Product Code | MXW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2006-03-06 |
| Summary: | summary |