510(k) K132124 ยท IYE Accelerator, Linear, Medical
KLARITY VACUUM BAG, KLARITY MOLD CUSHION
| Applicant | Klarity Medical Products, LLC, Newark OH, US |
| Decision | Substantially Equivalent, Nov 1, 2013 |
| Received | Jul 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2020 | Klarity Medical Products LLC Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and position Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.