510(k) K963950 ยท EXI Device, Paste-On For Incontinence, Sterile
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
| Applicant | Bioderm, Inc., East Burnswick NJ, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Oct 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963950
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.