Optim, LLC · Class II · Cleared Sep 13, 2012
| K-number | K122593 |
| Device name | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 |
| Applicant | Optim, LLC |
| Product code | FEH |
| Device class | Class II |
| Decision date | Sep 13, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
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