510(k) K955856 ยท LKY Device, External Penile Rigidity
TEX-AID BLUE
| Applicant | Laborie Medical Technologies, Ltd., Mississauga Ont. Canada, CA |
| Decision | Substantially Equivalent, Feb 16, 1996 |
| Received | Dec 26, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955856
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.