Bioenterics Corp. · Class I · Cleared Feb 11, 1997
| K-number | K964561 |
| Device name | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA |
| Applicant | Bioenterics Corp. |
| Product code | FDG |
| Device class | Class I |
| Decision date | Feb 11, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 876.4530 |
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