510(k) K053322 ยท FAS Electrode, Electrosurgical, Active, Urological
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
| Applicant | Roei Medical Technologies, Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Jan 6, 2006 |
| Received | Nov 30, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053322
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.