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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 K202457
Device Name M1 Surgical Face Mask
Applicant
CHISON Medical Technologies Co., Ltd.
#228, Changjiang E. Rd., Block 51 And 53, Phase 5,
Shuofang Industrial Park, Xinwu District
Wuxi,  CN 214142
Applicant Contact Qifei Liu
Correspondent
CHISON Medical Technologies Co., Ltd.
#228, Changjiang E. Rd., Block 51 And 53, Phase 5,
Shuofang Industrial Park, Xinwu District
Wuxi,  CN 214142
Correspondent Contact Qifei Liu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/27/2020
Decision Date 04/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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