510(k) K052953
- Device
- NUVANCE* FACIAL REJUVENATION SYSTEM
- Applicant
- ETHICON, INC.
- 510(k) number
- K052953
- Product code
- MXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-06
- Date received
- 2005-10-20
- Regulation
- 878.5010
- Classification name
- Suture, Surgical, Nonabsorbable, Poly (vinylidene Fluoride)
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER M PAINE
- Address
- Rt. 22 W. P.O. Box 151 Sommerville NJ US 08876 08876
FDA Registration Numbers#
- 3014592276
- 9611459
- 3015330532
Source Documents#
Other 510(k) Records For Product Code MXW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060465 | PREMIO | Peters Surgical | 2007-01-17 |
Legacy Summary#
summary
FDA Review#
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