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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mask, surgical
510(k) Number K173062
Device Name Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))
Applicant
V&Q Manufacturing Corporation
#B1614 optical valley time square,
Wuhan,  CN 430074
Applicant Contact Jacky Jin
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No 22
Guimiao Road
Shenzhen,  CN 518000
Correspondent Contact Tracy Che
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/28/2017
Decision Date 01/25/2018
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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