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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 K202903
Device Name Surgical Face Mask
Applicant
Rizhao Sanqi Medical & Health Articles Co., Ltd.
Heshan Industry Park, Donggang Distric
Rizhao,  CN 276823
Applicant Contact Julia Yu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1309, Dongfang Bldg., 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/29/2020
Decision Date 03/24/2022
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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