510(k) K101617 ยท ELW Material, Impression
FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
| Applicant | Heraeus Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Sep 7, 2010 |
| Received | Jun 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101617
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.