510(k) K944393 ยท FYA Gown, Surgical
STRYKER STERI-SHIELD SURGICAL APPAREL
| Applicant | Stryker Corp., Kalamazoo MI, US |
| Decision | Substantially Equivalent, Aug 28, 1995 |
| Received | Sep 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2012 | Stryker Instruments Div. of Stryker Corporation T5 Hytrel Zipper Toga.
Product Usage:
The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/o Terminated |
FYA | None listed |
| Jun 14, 2012 | Stryker Instruments Div. of Stryker Corporation T4-Hytrel Zipper Toga
Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/o Terminated |
FYA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.