K190342 is an FDA 510(k) clearance for the BIAFINE Topical Cream. This device is classified as a Dressing, Wound, Drug.
Submitted by Bausch Health Americas Incorporated (Rochester, US). The FDA issued a Cleared decision on October 18, 2019, 246 days after receiving the submission on February 14, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K190342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |