The following data is part of a premarket notification filed by Allwin Medical Devices, Inc. with the FDA for 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, Fle.
| Device ID | K190522 |
| 510k 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, FLE |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Allwin Medical Devices, Inc. 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 |
| Contact | Digish Mehta |
| Correspondent | Digish Mehta Allwin Medical Devices, Inc. 3305 E. Miraloma Avenue, Suite 176 Anaheim, CA 92806 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-11-14 |