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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 K212299
Device Name Medical Surgical Mask
Applicant
Wepon Medical Technology Co., Ltd.
West Side Of N. Baizhang Rd., Chengdong St.
Wenling,  CN 317500
Applicant Contact Yongxian Sun
Correspondent
Wepon Medical Technology Co., Ltd.
West Side Of N. Baizhang Rd., Chengdong St.
Wenling,  CN 317500
Correspondent Contact Yongxian Sun
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/22/2021
Decision Date 01/04/2022
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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