510(k) K771615 ยท ESH Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
AUDI-SIL EARMOLD MATERIAL
| Applicant | Coe Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 30, 1977 |
| Received | Aug 24, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771615
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.