510(k) K030170 ยท OCW Endoscopic Tissue Approximation Device
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Jul 28, 2003 |
| Received | Jan 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030170
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.