510(k) K083802 ยท FCG Biopsy Needle
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
| Applicant | Medi-Globe Corporation, Tempe AZ, US |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Dec 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083802
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.