Device Classification Name |
mask, surgical
|
510(k) Number |
K213920 |
Device Name |
Kangbeier Surgical Mask (Model: KBR-1001) |
Applicant |
Xinxiang Kangbeier Medical Technology Co., Ltd. |
East Mancun Industrial District |
Changyuan,
CN
48105
|
|
Applicant Contact |
Shaoju Tian |
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 | 12/15/2021 |
Decision Date | 01/16/2022 |
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
|
|
|