Cook Incorporated · Class II · Cleared Oct 24, 2018
| K-number | K180302 |
| Device name | Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator, Soft-Trans Malleable Obturator, Guardia ETS Embryo-Tested Syringe, Flushing Catheter |
| Applicant | Cook Incorporated |
| Product code | MQF |
| Device class | Class II |
| Decision date | Oct 24, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 884.6110 |
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