510(k) K891161 ยท HQC Unit, Phacofragmentation
VITRECTOMY PACK #J120
| Applicant | O.R. Specialties, Inc., Tuscaloosa AL, US |
| Decision | Substantially Equivalent, May 26, 1989 |
| Received | Mar 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891161
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.