510(k) K003338 ยท HPZ Implant, Eye Sphere
BIO-EYE II ORBITAL IMPLANT
| Applicant | Integrated Orbital Implants, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 7, 2001 |
| Received | Oct 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2011 | Integrated Orbital Implants Inc Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer.
Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital.
Model Number: I0016C, I0018C, I0020C, I0022C, I0024C.
Description o Terminated |
HPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.