510(k) K062465 ยท HNO Keratome, Ac-Powered
ZYOPTIX XP EPI SEPARATOR SYSTEM
| Applicant | Bausch & Lomb, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Sep 6, 2006 |
| Received | Aug 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2007 | Bausch & Lomb Inc Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactu Terminated |
HNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.