510(k) K897005 ยท JOH Tube Tracheostomy And Tube Cuff
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
| Applicant | Helix Medical, Inc., Santa Barbera CA, US |
| Decision | Substantially Equivalent, Mar 16, 1990 |
| Received | Dec 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897005
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.