SERI Contour— 510(k) K172545
Substantially EquivalentSofregen Medical, Inc.
FDA 510(k) clearance K172545 for SERI Contour, Substantially Equivalent on 2017-09-22. Applicant: Sofregen Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sofregen Medical, Inc.
- Product code
- Code OXF
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Medford, MA, US
Recent devices under product code OXF
view allMore clearances from Sofregen Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.