K110554
Substantially EquivalentBIOCERAMIC ORBITAL IMPLANT, ORBTEX
- Applicant
- Ceramisys, Ltd.
- Product code
- HPZ
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Centercille, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.