510(k) K981637 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
| Applicant | Linvatec Corp., Largo FL, US |
| Decision | Substantially Equivalent, Jul 20, 1998 |
| Received | May 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981637
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.