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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 K221196
Device Name Disposable Medical Face Mask (ear loop)
Applicant
Xiantao Topmed Nonwoven Protective Products Co., Ltd.
North Of The National Rd. 318,
Tongjiazui Village,Huchang Town
Xiantao,  CN 433000
Applicant Contact Vivian Zhu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/25/2022
Decision Date 07/22/2022
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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