510(k) K080904 ยท FMI Needle, Hypodermic, Single Lumen
FEEL-FINE INSULIN PEN NEEDLE
| Applicant | Feel Tech, Deer Field IL, US |
| Decision | Substantially Equivalent, Jun 4, 2008 |
| Received | Apr 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to be used as an insulin Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21 Terminated |
FMF | None listed |
| Dec 28, 2009 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-21 Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.