510(k) K000545 ยท GCJ Laparoscope, General & Plastic Surgery
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
| Applicant | Applied Medical Resources, Launa Hills CA, US |
| Decision | Substantially Equivalent, May 2, 2000 |
| Received | Feb 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000545
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.