510(k) K063146 ยท KZH Introducer, Syringe Needle
ACCU-CHEK LINKASSIST
| Applicant | Disetronic Medical Systems AG, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 27, 2006 |
| Received | Oct 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063146
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.