Device Classification Name |
Mask, Surgical
|
510(k) Number |
K210487 |
Device Name |
MIPLNI YK-244 Disposable Surgical Mask |
Applicant |
Hunan Yuankang Biological Technology Co., Ltd |
Heping Team, Sanlian Community, Xidu Town |
Hengyang,
CN
421000
|
|
Applicant Contact |
Kylin Rui Chen |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 02/19/2021 |
Decision Date | 03/16/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|