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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 K210643
Device Name Disposable Surgical Face Mask
Applicant
Shandong Zhushi Pharmaceutical Group Co., Ltd.
# 6, Shande Rd., Shan County
Heze,  CN 274300
Applicant Contact Junhui Zhu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/03/2021
Decision Date 08/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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