K190224 is an FDA 510(k) clearance for the Medline Burn and Wound Dressing (OTC). This device is classified as a Dressing, Wound, Drug.
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on March 8, 2019, 31 days after receiving the submission on February 5, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K190224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2019 |
| Decision Date | March 08, 2019 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |