The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co, Ltd with the FDA for Luofucon Silver Foam Dressing.
| Device ID | K141619 |
| 510k Number | K141619 |
| Device Name: | LUOFUCON SILVER FOAM DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 853 DORCHESTER LN, UNIT-B New Milford, NJ 07646 |
| Contact | Charles Shen |
| Correspondent | Charles Shen HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 853 DORCHESTER LN, UNIT-B New Milford, NJ 07646 |
| 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 | 2014-06-17 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00324357010889 | K141619 | 000 |
| 00324357010667 | K141619 | 000 |
| 00324357010452 | K141619 | 000 |
| 00324357010223 | K141619 | 000 |