510(k) K012464 ยท FQH Lavage, Jet
HELIX HYDRO-JET
| Applicant | Andreas Pein Medizintechnik GmbH, Golden CO, US |
| Decision | Substantially Equivalent, Oct 10, 2001 |
| Received | Aug 1, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012464
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.