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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 K210225
Device Name Surgical Face Mask
Applicant
Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd
Room 1304, Technology Innovation Park,
Shajing Dahong (Xinqiao), Baoan District
Shenzhen,  CN 518000
Applicant Contact Qiyuan Ning
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/28/2021
Decision Date 03/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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