510(k) K972865 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
PROMEX ENT TISSUE REMOVAL SYSTEM
| Applicant | Promex, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 29, 1997 |
| Received | Aug 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972865
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.