510(k) K970716 ยท EZL Catheter, Retention Type, Balloon
OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
| Applicant | Opticon Medical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 16, 1997 |
| Received | Feb 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970716
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.