510(k) K123396 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
I.FLEX BY TCS
| Applicant | Thermoplastic Comfort Systems, Inc., Signal Hill CA, US |
| Decision | Substantially Equivalent, Jan 10, 2013 |
| Received | Nov 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123396
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.