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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 K201871
Device Name Surgical Mask
Applicant
C & S Paper Yunfu Co., Ltd.
# 168 Longbao Rd., Shuangdong St.
Luoding,  CN
Applicant Contact Xu Zhiming
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/07/2020
Decision Date 08/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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