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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 K212826
Device Name Disposable Medical Mask
Applicant
Jiangsu Nanfang Medical Co., Ltd.
# 1 Guoxiang Rd., Wujin Economic Development Zone, Wujin
Changzhou,  CN 213149
Applicant Contact Li Xia
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/03/2021
Decision Date 01/19/2022
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
Predetermined Change
Control Plan Authorized		 No
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