Device Classification Name |
Mask, Surgical
|
510(k) Number |
K203425 |
Device Name |
Surgical Mask |
Applicant |
BDC Dental Corporation Ltd. |
Part 3, No.1 Guanchong Section, Shilian Rd. |
Shiji Town, Panyu District |
Guangzhou,
CN
511450
|
|
Applicant Contact |
Lifang Zhang |
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 | 11/20/2020 |
Decision Date | 03/05/2021 |
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
|
|
|