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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 K200923
Device Name Single-use Surgical Mask
Applicant
BYD Precision Manufacturer Co.Ltd.
No.3001 Baohe Road, Baolong Industrial Area, Longgang
Shenzhen,  CN 518116
Applicant Contact Yubo Guan
Correspondent
Nova Clinical Solutions, Inc.
6792 Solterra Vista Pkwy
San Diego,  CA  92130
Correspondent Contact Annie Zhang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/07/2020
Decision Date 08/26/2020
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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