510(k) K033653 ยท HQC Unit, Phacofragmentation
VENTURI PHACO PACK
| Applicant | Bausch & Lomb, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 17, 2003 |
| Received | Nov 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033653
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle w Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and DP4310E, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle w Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb Millennium Micro Incision Premium Venturi Pack, Model CX4320, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wre Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.