510(k) K971517 ยท EWD Protector, Hearing (Insert)
SILICONE PUTTY EAR PLUGS
| Applicant | Bentec Medical, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Jun 2, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971517
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.