The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Silver Wound Gel, Luofucon Silver Antimicrobial Wound Gel.
| Device ID | K211123 |
| 510k Number | K211123 |
| Device Name: | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | Huizhou Foryou Medical Devices CO., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, CN 516005 |
| Contact | Huiqi Huang |
| Correspondent | Huiqi 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 | 2021-04-15 |
| Decision Date | 2022-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810113576692 | K211123 | 000 |