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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 K212726
Device Name Disposable Medical Surgical Mask
Applicant
Hubei Huaqiang High-Tech Co., Ltd.
#499 Donglin Rd.
Yichang,  CN 443000
Applicant Contact Jing Yang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/27/2021
Decision Date 03/23/2022
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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