510(k) K983974 ยท FMF Syringe, Piston
OWEN MUMFORD 3ML AUTOPEN
| Applicant | Owen Mumford USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Dec 21, 1998 |
| Received | Nov 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983974
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2015 | Owen Mumford USA, Inc. Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01,
The product is a non-sterile automatic subcutaneous injection device which delivers ins Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.