510(k) K853295 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
EMODREN EXCHANGEABLE PLASTIC BELLOWS
| Applicant | Parexel Intl. Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Aug 20, 1985 |
| Received | Aug 6, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853295
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.