| K-number | K191908 |
| Device name | MTS Imipenem 0.016-256 µg/mL |
| Applicant | Liofilchem s.r.l. |
| Product code | JWY |
| Device class | Class II |
| Decision date | Sep 4, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 866.1640 |
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