510(k) K961697 ยท EZL Catheter, Retention Type, Balloon
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
| Applicant | Medical Device Intl., Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Aug 30, 1996 |
| Received | May 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961697
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.