510(k) K982128 ยท JOH Tube Tracheostomy And Tube Cuff
SHIKANI-FRENCH SPEAKING VALVE
| Applicant | Pilling Weck Surgical, Fort Washington PA, US |
| Decision | Substantially Equivalent, Oct 23, 1998 |
| Received | Jun 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982128
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.