Promamedical, Inc. · Class II · Cleared Oct 5, 2023
| K-number | K230070 |
| Device name | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® |
| Applicant | Promamedical, Inc. |
| Product code | FMI |
| Device class | Class II |
| Decision date | Oct 5, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 880.5570 |
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