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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 K210487
Device Name MIPLNI YK-244 Disposable Surgical Mask
Applicant
Hunan Yuankang Biological Technology Co., Ltd
Heping Team, Sanlian Community, Xidu Town
Hengyang,  CN 421000
Applicant Contact Kylin Rui Chen
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 Received02/19/2021
Decision Date 03/16/2021
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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