Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K201016 |
Device Name |
LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) |
Applicant |
Huizhou Foryou Medical Devices Co., Ltd. |
No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park |
Huizhou,
CN
516005
|
|
Applicant Contact |
Guosheng Tan |
Correspondent |
Huizhou Foryou Medical Devices Co., Ltd. |
No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park |
Huizhou,
CN
516005
|
|
Correspondent Contact |
Guosheng Tan |
Classification Product Code |
|
Date Received | 04/17/2020 |
Decision Date | 01/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|