The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Silver Pu Antibacterial Foam Dressing.
| Device ID | K140954 |
| 510k Number | K140954 |
| Device Name: | LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. P.O. BOX 120-119 Shanghai, CN 200120 |
| 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 | 2014-04-14 |
| Decision Date | 2015-03-23 |
| Summary: | summary |