510(k) K082114 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
| Applicant | Apollo Endosurgery, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Jul 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082114
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.