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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number878.4040
Classification Product Code
OUK  
Subsequent Product Code
OXZ  
Date Received08/05/2019
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
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