K170077 is an FDA 510(k) clearance for the LUOFUCON Silicone Ag Foam Dressing with Border. This device is classified as a Dressing, Wound, Drug.
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on March 30, 2017, 80 days after receiving the submission on January 9, 2017.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K170077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2017 |
| Decision Date | March 30, 2017 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |