Device Classification Name |
mask, surgical
|
510(k) Number |
K202240 |
Device Name |
Disposable Surgical Mask/Fluid Resistant Procedure Mask |
Applicant |
LHM Medical Technology (Hong Kong) Limited |
Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, |
7 Ko Fai Road,Yau Tong |
HongKong,
CN
999077
|
|
Applicant Contact |
Frank Cheng |
Correspondent |
LHM Medical Technology (Hong Kong) Limited |
Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, |
7 Ko Fai Road,Yau Tong |
HongKong,
CN
999077
|
|
Correspondent Contact |
Frank Cheng |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 08/10/2020 |
Decision Date | 02/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|