510(k) K970814 ยท FYC Gown, Isolation, Surgical
NON-STERILE ISOLATION GOWN
| Applicant | American Seal Co., Hayward CA, US |
| Decision | Substantially Equivalent, May 27, 1997 |
| Received | Mar 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970814
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.