510(k) K980466 ยท JOH Tube Tracheostomy And Tube Cuff
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
| Applicant | Sims Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Feb 24, 1998 |
| Received | Feb 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980466
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Smiths Medical ASD, Inc. PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube
REF # 511080 Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.