The following data is part of a premarket notification filed by Ulab Systems, Inc. with the FDA for Ulab Systems Udesign Software.
| Device ID | K200772 |
| 510k Number | K200772 |
| Device Name: | ULab Systems UDesign Software |
| Classification | Orthodontic Software |
| Applicant | ULab Systems, Inc. 1820 Gateway Drive, Suite 300 San Mateo, CA 94404 |
| Contact | Charlie Wen |
| Correspondent | Sylvia Erickson Sylvia Erickson Consulting 157 Ruby Avenue San Carlos, CA 94070 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-25 |
| Decision Date | 2020-06-23 |