510(k) K133527 ยท ELW Material, Impression
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
| Applicant | Osstem Germany GmbH, Fariless Hills PA, US |
| Decision | Substantially Equivalent, Mar 7, 2014 |
| Received | Nov 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133527
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.