K192478 is an FDA 510(k) clearance for the LT Antibacterial Alginate with Silver Dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Zhejiang Longterm Medical Technology Co., Ltd. (Deqing, CN). The FDA issued a Cleared decision on June 17, 2020, 281 days after receiving the submission on September 10, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K192478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2019 |
| Decision Date | June 17, 2020 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |