510(k) K964561 ยท FDG Retractor, Fiberoptic
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
| Applicant | Bioenterics Corp., Carpinteria CA, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Nov 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964561
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.