510(k) K053262 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
| Applicant | KARL STORZ Endoscopy-America, Inc., Culver City CA, US |
| Decision | Substantially Equivalent, Dec 19, 2005 |
| Received | Nov 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053262
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.