510(k) K971064 ยท HQC Unit, Phacofragmentation
BAYERS BIMANUAL I/A HANDPIECES
| Applicant | Visioncare Devices, Inc., Redding CA, US |
| Decision | Substantially Equivalent, Jun 9, 1997 |
| Received | Mar 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971064
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.