510(k) K981612 ยท EZL Catheter, Retention Type, Balloon
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, Jul 8, 1998 |
| Received | May 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981612
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.