510(k) K953539 ยท HQC Unit, Phacofragmentation
DM001 DISPOSABLE PACK
| Applicant | American Optisurgical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 26, 1995 |
| Received | Jul 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953539
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.