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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 K220824
Device Name Medical Surgical Mask (Planar type)
Applicant
Hunan Chopard Medical Devices Co., Ltd.
88, Tongxin Rd., Longfu Town Industrial District,
Liuyang City, Hunan Province
Liuyang,  CN
Applicant Contact Hongwei Wei
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/21/2022
Decision Date 05/19/2022
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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