510(k) K941391 ยท GBT Catheter, Rectal
INFLATABLE RETENTION CUFF SPECULUM
| Applicant | Innovatec Medical Corp., Duluth GA, US |
| Decision | Substantially Equivalent, Oct 20, 1994 |
| Received | Mar 22, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941391
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.