510(k) K905195 ยท LKY Device, External Penile Rigidity
FIRM MASTER
| Applicant | Bak Medical Products, Martinez CA, US |
| Decision | Substantially Equivalent, Feb 1, 1991 |
| Received | Nov 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905195
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.