510(k) K963809 ยท FYA Gown, Surgical
COOL-ZONE
| Applicant | Kappler USA, Guntersville AL, US |
| Decision | Substantially Equivalent, Nov 20, 1996 |
| Received | Sep 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963809
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.