The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Extra Silver Alginate Dressing, Luofucon Extra Antibacterial Alginate Dressing.
| Device ID | K172554 |
| 510k Number | K172554 |
| Device Name: | LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, CN 516005 |
| Contact | Huida Huang |
| Correspondent | Huida Huang Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., 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 | 2017-08-24 |
| Decision Date | 2018-05-01 |
| Summary: | summary |