510(k) K863943 ยท HPZ Implant, Eye Sphere
POREX(TM) EYE SPHERE IMPLANT
| Applicant | Porex Medical, Fairburn GA, US |
| Decision | Substantially Equivalent, Feb 27, 1987 |
| Received | Oct 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863943
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2005 | Porex Surgical, Inc. MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Roa Terminated |
HPZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.