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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 K202615
Device Name Nordiwell Medical Face Mask
Applicant
Changzhou Combat Protective Equipment Co., Ltd.
Qingsitang Village, Henglin Town, Wujin District
Changzhou,  CN 213101
Applicant Contact Yanmei Song
Correspondent
Changzhou Combat Protective Equipment Co., Ltd.
Qingsitang Village, Henglin Town, Wujin District
Changzhou,  CN 213101
Correspondent Contact Yanmei Song
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/09/2020
Decision Date 12/31/2020
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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