510(k) K081388 ยท NDC Calculator, Drug Dose
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
| Applicant | Pronia Medical System, LLC, North Attleboro MA, US |
| Decision | Substantially Equivalent, Aug 21, 2008 |
| Received | May 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081388
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.