510(k) K101359 ยท FMF Syringe, Piston
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
| Applicant | Inviro Medical Devices, Inc., Lawrenceville GA, US |
| Decision | Substantially Equivalent, Aug 20, 2010 |
| Received | May 14, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2020 | Cardinal Health 200, LLC Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the b Terminated |
KMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.