Device Classification Name |
Mask, Surgical
|
510(k) Number |
K213736 |
Device Name |
Medical Face Mask |
Applicant |
Hangzhou Runheng Medical Co., Ltd. |
Room 201, Shunfeng Building, NO.109 Hongxing Road, |
Qiaonan Block |
Hangzhou,
CN
311215
|
|
Applicant Contact |
Yaya Lu |
Correspondent |
Hangzhou Runheng Medical Co., Ltd. |
Room 201, Shunfeng Building, NO.109 Hongxing Road, |
Qiaonan Block |
Hangzhou,
CN
311215
|
|
Correspondent Contact |
Yaya Lu |
Regulation Number | 878.4040 |
Classification Product Code |
|
Date Received | 11/29/2021 |
Decision Date | 03/31/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|