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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 K212526
Device Name Surgical Face Mask
Applicant
Suzhou JaneE Medical Technology Co., Ltd.
No.339 HuaFeng Road, New District
Suzhou,  CN 215129
Applicant Contact Chen Ke
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/11/2021
Decision Date 11/09/2021
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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