510(k) K974196 ยท LKY Device, External Penile Rigidity
MEGAVAC SYSTEM
| Applicant | Barry J. Kaplan, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Nov 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974196
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.