510(k) K905042 ยท EZL Catheter, Retention Type, Balloon
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, Jan 18, 1991 |
| Received | Nov 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905042
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.