The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Silicone Ag Foam Dressing.
| Device ID | K160022 |
| 510k Number | K160022 |
| Device Name: | LUOFUCON Silicone Ag Foam Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. NORTH SHANGXIA ROAD DONGJIANG HI-TECH INDUSTRY PARK Huizhou, CN 516005 |
| Contact | Guosheng Tan |
| Correspondent | Guosheng Tan HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. NORTH SHANGXIA 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 | 2016-01-05 |
| Decision Date | 2016-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00714196932730 | K160022 | 000 |
| 04063591428208 | K160022 | 000 |
| 04063591428246 | K160022 | 000 |
| 04063591428291 | K160022 | 000 |
| 04063591428321 | K160022 | 000 |
| 04063591428376 | K160022 | 000 |
| 00714196391025 | K160022 | 000 |
| 00714196391049 | K160022 | 000 |
| 00714196391063 | K160022 | 000 |
| 00714196492203 | K160022 | 000 |
| 00714196494504 | K160022 | 000 |
| 00714196496607 | K160022 | 000 |
| 00714196932723 | K160022 | 000 |
| 00324357020444 | K160022 | 000 |