510(k) K974082 ยท LKY Device, External Penile Rigidity
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
| Applicant | Performance Plus, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Feb 27, 1998 |
| Received | Oct 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974082
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.