OsteoFab Patient Specific Facial Device— 510(k) K161052
Substantially EquivalentOxford Performance Materials, Inc.
FDA 510(k) clearance K161052 for OsteoFab Patient Specific Facial Device, Substantially Equivalent on 2016-07-20. Applicant: Oxford Performance Materials, Inc..
Clearance details
- Applicant
- Oxford Performance Materials, Inc.
- Product code
- Code KKY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Windsor, CT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.