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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 K212944
Device Name Disposable Surgical Mask
Applicant
Heilongjiang Yinjia Medical Equipment Co., Ltd.
F3-4, Plant 6, #10, Hanan 12th Rd., Nangang District
Harbin,  CN 150000
Applicant Contact Zhu Hongwei
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/13/2021
Decision Date 12/15/2021
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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