K181315 is an FDA 510(k) clearance for the Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing. This device is classified as a Dressing, Wound, Drug.
Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 14, 2019, 272 days after receiving the submission on May 18, 2018.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K181315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2018 |
| Decision Date | February 14, 2019 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |