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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 K210042
Device Name Disposable Surgical Mask
Applicant
Suzhou Letian Protective Products Co., Ltd.
No. 12 Zhenfeng Road, Nanfeng Town
Suzhou,  CN 215600
Applicant Contact Huang Qizhi
Correspondent
Shanghai Mind-link Business Consulting Co., Ltd.
Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District
Shanghai,  CN 200040
Correspondent Contact Ryan Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/07/2021
Decision Date 11/17/2021
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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