510(k) K972034 ยท HQN Conformer, Ophthalmic
MEDPOR OCULAR CONFORMER
| Applicant | Porex Surgical, Inc., Fairburn GA, US |
| Decision | Substantially Equivalent, Jan 20, 1998 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Porex Surgical, Inc. Ocular Conformer, Sterile, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265.
The device is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process Terminated |
HQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.