510(k) K060465
- Device
- PREMIO
- Applicant
- Peters Surgical
- 510(k) number
- K060465
- Product code
- MXW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-17
- Date received
- 2006-02-22
- 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
- N
Applicant Contact#
- Contact
- ANNIE LASSERRE
- Address
- 42 Rue Benoit Frachon Z.I. Les Vignes Bobigny FR 93013 93013
FDA Registration Numbers#
- 3014592276
- 9611459
- 3015330532
Source Documents#
Other 510(k) Records For Product Code MXW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052953 | NUVANCE* FACIAL REJUVENATION SYSTEM | ETHICON, Inc. | 2006-03-06 |