510(k) K971627 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
SILICONE ANTIBACTERIAL FOLEY CATHETER
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, Jan 13, 1998 |
| Received | May 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971627
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.