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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 K212235
Device Name Surgical Face Mask
Applicant
Shanghai Yunqing Industrial Co., Ltd.
2nd Bldg. 1818, Shangsu Rd., Fengxian District
Shanghai,  CN 210000
Applicant Contact Hulin No Last Name Provided
Correspondent
Shanghai Mind-Link Business Consulting Co., Ltd.
Rm. A08, Floor 14th, No 699, Jiaozhou Rd., Jingan District
Shanghai,  CN 200040
Correspondent Contact Ryan Li
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/19/2021
Decision Date 12/06/2021
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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