510(k) K952114 ยท FYC Gown, Isolation, Surgical
KOOL GARD SINGLES GOWN
| Applicant | American Threshold Industries, Inc., Enka NC, US |
| Decision | Substantially Equivalent, Sep 25, 1995 |
| Received | May 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952114
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.