Device Classification Name |
N95 Respirator With Antimicrobial/Antiviral Agent
|
510(k) Number |
K122702 |
Device Name |
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR |
Applicant |
FILLIGENT LIMITED |
7TH FLLOR, 69 JERVOIS STREET, |
SHEUNG WAN |
HONG KONG,
CN
HK
|
|
Applicant Contact |
KAI DEUSCH |
Correspondent |
FILLIGENT LIMITED |
7TH FLLOR, 69 JERVOIS STREET, |
SHEUNG WAN |
HONG KONG,
CN
HK
|
|
Correspondent Contact |
KAI DEUSCH |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 03/18/2013 |
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
|
|
|