Device Classification Name |
mask, surgical
|
510(k) Number |
K202708 |
Device Name |
Surgical Face Masks |
Applicant |
Intco Medical(HK) Co., Ltd. |
Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai |
Hong Kong,
CN
999077
|
|
Applicant Contact |
Max Li |
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 | 09/16/2020 |
Decision Date | 03/30/2021 |
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
|
|
|