510(k) K954401 ยท ESI Polymer, Natural-Absorbable Gelatin Material
GASTROTEC
| Applicant | Patrick C. Jacobssen, Fairhope AL, US |
| Decision | Substantially Equivalent, Apr 25, 1996 |
| Received | Sep 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954401
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.