Device Classification Name |
Mask, Surgical
|
510(k) Number |
K221352 |
Device Name |
Surgical Face Mask |
Applicant |
Wuhan Huashida Protective Products Co., Ltd. |
No.511 Weihu Rd, Shamao St, Hannan district |
Wuhan,,
CN
430090
|
|
Applicant Contact |
Chen Mei |
Correspondent |
Wuhan Huashida Protective Products Co., Ltd. |
No.511 Weihu Rd, Shamao St, Hannan district |
Wuhan,,
CN
430090
|
|
Correspondent Contact |
Chen Mei |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 05/10/2022 |
Decision Date | 03/13/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|