The following data is part of a premarket notification filed by Allwin Medical Devices, Inc. with the FDA for Allwin Embryo Transfer Catheters (etc), Allwin Etc Stylets And Soft Obturators.
| Device ID | K200248 |
| 510k Number | K200248 |
| Device Name: | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets And Soft Obturators |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Allwin Medical Devices, Inc. 3305 East Mira Loma Avenue, STE 176 Anaheim, CA 92806 |
| Contact | Digish Mehta |
| Correspondent | Digish Mehta Allwin Medical Devices, Inc. 3305 East Mira Loma Avenue, STE 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 | 2020-01-31 |
| Decision Date | 2020-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10819374022535 | K200248 | 000 |
| 10819374022528 | K200248 | 000 |