510(k) K112789 ยท FMI Needle, Hypodermic, Single Lumen
EASY TOUCH
| Applicant | Mhc Medical Products, LLC, Naples FL, US |
| Decision | Substantially Equivalent, Dec 23, 2011 |
| Received | Sep 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2018 | MHC Medical Products LLC EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155)
Product Usage:
INTENDED FOR INJECTION OF U100 INSULIN ONLY Open, Classified |
FMI | None listed |
| Apr 6, 2018 | MHC Medical Products LLC EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555)
Product Usage:
INTENDED FOR INJECTION OF U100 INSULIN ONLY Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.