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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 K213724
Device Name Medical Surgical Mask
Applicant
Hunan Zhenheyikang Medical Instrument Co., Ltd.
#6 Bldg. Jingxiang Energy,#55 Xiaguang E. Rd.,
Gaoxin District
Xiangtan,  CN 411100
Applicant Contact Yilin Yin
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/26/2021
Decision Date 02/20/2022
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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