510(k) K101609 ยท LXH Orthopedic Manual Surgical Instrument
SELF RETAINING SOFT TISSUE RETRACTOR
| Applicant | Koros USA, Inc., Moorepark CA, US |
| Decision | Substantially Equivalent, Dec 9, 2010 |
| Received | Jun 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101609
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.