510(k) K083275 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
| Applicant | Max Endoscopy, Inc., Macedonia OH, US |
| Decision | Substantially Equivalent, Jun 9, 2009 |
| Received | Nov 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083275
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.