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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 K210256
Device Name CiRx (R) Surgical Mask
Applicant
Ningbo Shun Ye Medical Company, Ltd.
No.5 Industry Road, Zhangqi Industry Zone, Cixi
Ningbo,  CN 315313
Applicant Contact Frank Yu
Correspondent
Ningbo Shun Ye Medical Company, Ltd.
No.5 Industry Road, Zhangqi Industry Zone, Cixi
Ningbo,  CN 315313
Correspondent Contact Frank Yu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/01/2021
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
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