The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Phmb Alginate Dressing (rx Use), Luofucon Phmb Antibacterial Alginate Wound Dressing (otc Use).
| Device ID | K201016 |
| 510k Number | K201016 |
| Device Name: | LUOFUCON PHMB Alginate Dressing (Rx Use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC Use) |
| Classification | Dressing, Wound, Drug |
| Applicant | Huizhou Foryou Medical Devices Co., Ltd. No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou, CN 516005 |
| Contact | Guosheng Tan |
| Correspondent | Guosheng Tan Huizhou Foryou Medical Devices Co., Ltd. No. 1 Shangxia North Road, Dongjiang Hi-tech Industry 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 | 2020-04-17 |
| Decision Date | 2021-01-28 |