510(k) K120521 ยท ELW Material, Impression
GC BLUE SILICONE
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, May 10, 2012 |
| Received | Feb 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120521
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.