Device Classification Name |
Surgical Mask With Antimicrobial/Antiviral Agent
|
510(k) Number |
K192105 |
Device Name |
Innonix Antiviral Child's Face Mask |
Applicant |
Innonix Technologies Limited |
13/F LiFung Centre, 2 On Ping Street |
Siu Lek Yuen,Shatin,
HK
|
|
Applicant Contact |
Tommy Lui |
Correspondent |
Innonix Technologies Limited |
10017 Sorrel Ave |
Potomac,
MD
20854
|
|
Correspondent Contact |
Reid Von Borsel |
Regulation Number | 878.4040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/05/2019 |
Decision Date | 11/29/2019 |
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
|