510(k) K053060 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
TCS UNBREAKABLE
| Applicant | Thermoplastic Comfort Systems, Inc., Signal Hill CA, US |
| Decision | Substantially Equivalent, Jul 20, 2006 |
| Received | Oct 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053060
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.