510(k) K993142 ยท LKY Device, External Penile Rigidity
ELITE CUSTOM
| Applicant | Soma Blue, Inc., Augusta GA, US |
| Decision | Substantially Equivalent, Dec 27, 1999 |
| Received | Sep 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993142
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.