The following data is part of a premarket notification filed by Allwin Medical Devices, Inc with the FDA for Surestrip Vitrification Straw, Surelock Vitrification Straw.
| Device ID | K203626 |
| 510k Number | K203626 |
| Device Name: | SureStrip Vitrification Straw, SureLock Vitrification Straw |
| Classification | Labware, 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 | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-11 |
| Decision Date | 2021-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10819374021569 | K203626 | 000 |
| 10819374021552 | K203626 | 000 |