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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 K203704
Device Name Surgical face mask
Applicant
Juntech(Jiaxing)Healthcare Materials Co,.Ltd
#4 Plant,No1 Build Of N. Of Yubei St., And Zhengdong Rd.,
Yuxin Town Nanhu District
Jiaxing,  CN 314009
Applicant Contact Cam Sun
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.218, Bldg. 2, Yike Intelligent Innovation Park,
# 232 Kezhu Rd., Huangpu, Guangzhou
Guangzhou,  CN 510000
Correspondent Contact Gamma Zhang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/18/2020
Decision Date 06/04/2021
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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