The following data is part of a premarket notification filed by Stemcyte Inc. with the FDA for Bonvadis Topical Cream.
| Device ID | K212554 |
| 510k Number | K212554 |
| Device Name: | Bonvadis Topical Cream |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | StemCyte Inc. 13800 Live Oak Avenue Baldwin Park, CA 91706 |
| Contact | Angel Hsieh |
| Correspondent | Angel Hsieh StemCyte Inc. 13800 Live Oak Avenue Baldwin Park, CA 91706 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-08-13 |
| Decision Date | 2022-08-19 |