510(k) K110554— BIOCERAMIC ORBITAL IMPLANT, ORBTEX

Substantially Equivalent

Ceramisys, Ltd.

Clearance details

Applicant: Ceramisys, Ltd.
Product code: Code HPZ
Advisory panel: Ophthalmic
Date received: 2011-02-28
Decision date: 2011-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centercille, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.