Allwin Medical Devices, Inc. · Class II · Cleared Nov 14, 2019
| K-number | K190522 |
| Device name | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) |
| Applicant | Allwin Medical Devices, Inc. |
| Product code | MQF |
| Device class | Class II |
| Decision date | Nov 14, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 884.6110 |
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