510(k) K972527 ยท FPA Set, Administration, Intravascular
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
| Applicant | Quality System Consulting, Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 18, 1997 |
| Received | Jul 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972527
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.