Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K220673 |
Device Name |
Sterile Silver Alginate Wound Dressing |
Applicant |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
No. 788, Bright Moon Road, Huangdao District |
Qingdao,
CN
266400
|
|
Applicant Contact |
Deng Yunlong |
Correspondent |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
No. 788, Bright Moon Road, Huangdao District |
Qingdao,
CN
266400
|
|
Correspondent Contact |
Deng Yunlong |
Classification Product Code |
|
Date Received | 03/07/2022 |
Decision Date | 03/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|