The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Extra Silver Gelling Fiber Dressing, Luofucon Silver Antibacterial Gelling Fiber Dressing.
| Device ID | K210718 |
| 510k Number | K210718 |
| Device Name: | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, CN 516005 |
| Contact | Junfeng Zhang |
| Correspondent | Junfeng Zhang Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, CN 516005 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-03-10 |
| Decision Date | 2022-03-23 |