510(k) K073017 ยท FYA Gown, Surgical
STRYKER STRI-SHIELD FLYTE TOGAS
| Applicant | Stryker Instruments, Instruments Div., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | Oct 25, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2015 | Stryker Instruments Div. of Stryker Corporation Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Adva Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.