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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 K220302
Device Name Disposable surgical face mask
Applicant
Shandong Aida Medical Products Co., Ltd.
Wangjiazhuang, Wangliu Strret Office, Weicheng District
Weifang,  CN 261053
Applicant Contact Wang Bing
Correspondent
Shandong Aida Medical Products Co., Ltd.
Wangjiazhuang, Wangliu St. Office, Weicheng District
Weifang,  CN 261053
Correspondent Contact Wang Bing
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/02/2022
Decision Date 11/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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