510(k) K003512 ยท HQC Unit, Phacofragmentation
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
| Applicant | A.R.C. Laser AG, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 8, 2001 |
| Received | Nov 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003512
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.