510(k) K944512 ยท BYP Mouthpiece, Breathing
TRUZONE PFM DISPOSABLE MOUTHPIECE
| Applicant | Monaghan Medical Corp., Plattsburgh NY, US |
| Decision | Substantially Equivalent, Nov 2, 1994 |
| Received | Sep 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944512
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.