510(k) K811160 ยท EXD Irrigator, Ostomy
SUR-FIT IRRIGATION SLEEVE
| Applicant | E. R. Squibb & Sons, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jun 2, 1981 |
| Received | Apr 28, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811160
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.