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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 K203078
Device Name CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
Applicant
Huizhou Tianchang Industrial Co., Ltd.
#2 Xingde E. Rd., Dongjiang Hi-Tech Industrial Park,
Zhongkai Hi-Tech Industrial Park, Shuikou Town, Huicheng Dis
Huizhou,  CN 516005
Applicant Contact Johnny Chan
Correspondent
Mhetra, LLC
848 Brickell Ave. Ph 5
Miami,  FL  33131
Correspondent Contact Viky Verna
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/13/2020
Decision Date 08/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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