510(k) K031262 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
| Applicant | Ndo Surgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, May 23, 2003 |
| Received | Apr 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031262
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.