510(k) K040014 ยท JOH Tube Tracheostomy And Tube Cuff
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
| Applicant | Portex , Ltd., Hyth, Kent, GB |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Dec 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040014
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.