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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 K210698
Device Name ECOMA Level 2 Disposable Surgical Mask with Ear Loops
Applicant
Xianning Eco Medical Articles Co., Ltd.
#16,Shutai St. High-Tech Industrial Zone
Xianning,  CN 437000
Applicant Contact Wei Zhou
Correspondent
Xianning Eco Medical Articles Co., Ltd.
#16,Shutai St. High-Tech Industrial Zone
Xianning,  CN 437000
Correspondent Contact Wei Zhou
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/08/2021
Decision Date 08/19/2021
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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