510(k) K082454 ยท FMF Syringe, Piston
MICROMYST APPLICATOR, MODEL 20-5000
| Applicant | Covidien, Waltham MA, US |
| Decision | Substantially Equivalent, Nov 7, 2008 |
| Received | Aug 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids. Open, Classified |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.