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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 K220597
Device Name Disposable Surgical Face Mask (FM-34EE,FM-44EE)
Applicant
Qingdao Bestex Rubber & Plastic Products Co.,Ltd.
No.8-5 Guangzhou Road, Pingdu
Qingdao,  CN 266701
Applicant Contact Lucy Wang
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/01/2022
Decision Date 05/26/2022
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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