510(k) K071553 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
| Applicant | Ndo Surgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Sep 18, 2007 |
| Received | Jun 6, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071553
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.