510(k) K965165 ยท ELW Material, Impression
CUTTERSIL COMFORT HARDENER
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Mar 19, 1997 |
| Received | Dec 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965165
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.