510(k) K963391 ยท MPU Source, Chemiluminescent Light
SPECULITE
| Applicant | Trylon Corp., Monarch Beach CA, US |
| Decision | Substantially Equivalent, Dec 12, 1997 |
| Received | Aug 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2003 | Watson Diagnostics Inc. Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box. Terminated |
MPU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.