510(k) K982562 ยท HPZ Implant, Eye Sphere
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
| Applicant | Integrated Orbital Implants, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 28, 1998 |
| Received | Jul 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982562
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2010 | Integrated Orbital Implants Inc Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer Terminated |
HPZ | None listed |
| Oct 4, 2006 | Integrated Orbital Implants Inc Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S Terminated |
HPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.