The following data is part of a premarket notification filed by Bausch Health Americas Incorporated with the FDA for Biafine Topical Cream.
| Device ID | K190342 |
| 510k Number | K190342 |
| Device Name: | BIAFINE Topical Cream |
| Classification | Dressing, Wound, Drug |
| Applicant | Bausch Health Americas Incorporated 1400 N. Goodman St. 14609 USA Rochester, NY 14609 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi Bausch Health Americas Incorporated 1400 N. Goodman St. 14609 USA Rochester, NY 14609 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-02-14 |
| Decision Date | 2019-10-18 |