510(k) K970443 ยท EXI Device, Paste-On For Incontinence, Sterile
HOLLISTER RETRACTED PENIS POUCH
| Applicant | Hollister, Inc., Libertyville IL, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Feb 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970443
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.