510(k) K970966 ยท EXJ Device, Incontinence, Urosheath Type, Sterile
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
| Applicant | Sierra Laboratories, Inc., Tucson AZ, US |
| Decision | Substantially Equivalent, Apr 22, 1997 |
| Received | Mar 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970966
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.