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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 K210970
Device Name Single-Use Surgical Mask Model FE2311B
Applicant
Byd Precison Manufacturer Co., Ltd.
#3001 Baohe Rd. Baolong Industrial Area, Longgang
Shenzhen,  CN 518116
Applicant Contact Yubo Guan
Correspondent
Global Healthcare Product Solutions, LLC
1800 S. Figueroa St.
Los Angeles,  CA  90015
Correspondent Contact Jenny Jing
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/31/2021
Decision Date 07/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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