510(k) K033317 ยท OCW Endoscopic Tissue Approximation Device
SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Dec 30, 2003 |
| Received | Oct 15, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033317
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.