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 With Border.
| Device ID | K170077 |
| 510k Number | K170077 |
| Device Name: | LUOFUCON Silicone Ag Foam Dressing With Border |
| 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 | 2017-01-09 |
| Decision Date | 2017-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B492200663 | K170077 | 000 |
| 00324357030665 | K170077 | 000 |
| 04063591426150 | K170077 | 000 |
| 04063591428031 | K170077 | 000 |
| 04063591428079 | K170077 | 000 |
| 04063591428116 | K170077 | 000 |
| 04063591428154 | K170077 | 000 |
| 00714196391087 | K170077 | 000 |
| 00714196391100 | K170077 | 000 |
| 00714196391124 | K170077 | 000 |
| 00714196482204 | K170077 | 000 |
| 00714196484406 | K170077 | 000 |
| 00714196486608 | K170077 | 000 |
| 00714196932921 | K170077 | 000 |
| B492200442 | K170077 | 000 |
| 00324357030443 | K170077 | 000 |