510(k) K013519 ยท KLE Agent, Tooth Bonding, Resin
SIMPLE
| Applicant | Bisco, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Jan 17, 2002 |
| Received | Oct 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013519
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.