510(k) K946176 ยท HQC Unit, Phacofragmentation
STORZ PHACOEMULSIFICATION NEEDLES
| Applicant | Storz Instrument Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 14, 1995 |
| Received | Dec 19, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946176
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb 19G Standard 30 Phaco Needle, Model DP8130S, 6 pouches/box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the package Terminated |
HQC | None listed |
| May 28, 2010 | Bausch & Lomb Inc Bausch & Lomb 19G Standard 45 Phaco Needle, Model DP8145S, 6 pouches per box. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
The plastic needle wrench contained in the pack Terminated |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.