510(k) K952259 ยท HQC Unit, Phacofragmentation
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
| Applicant | Storz Instrument Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Jun 14, 1995 |
| Received | May 15, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952259
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | Bausch & Lomb Incorporated Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box. Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.