510(k) K980291 ยท LKY Device, External Penile Rigidity
IMPOWER EXTERNAL VACUUM SYSTEM
| Applicant | Imagyn Medical Technologies, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Mar 11, 1998 |
| Received | Jan 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980291
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.