510(k) K040996 ยท NIX Hearing Aid, Air Conduction, Transcutaneous System
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Aug 20, 2004 |
| Received | Apr 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040996
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.