510(k) K003994 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Apr 13, 2001 |
| Received | Dec 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003994
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.