510(k) K132729 ยท CBN Apparatus, Gas-Scavenging
ISO-GARD MASK
| Applicant | Teleflexmedical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Jan 9, 2014 |
| Received | Sep 3, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132729
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.