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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 K210744
Device Name Surgical Mask
Applicant
Chongqing PA Xijia Biotechnology Co., Ltd.
# 27-5, Fengsheng Rd., Jiulongpo District
Chongqing,  CN 400053
Applicant Contact Zheng Tao
Correspondent
Sichuan Jiuluehui Consulting Co., Ltd.
Rm. 1401, Bldg. 4, # 666, Chenglong Ave.
Chengdu,  CN 610101
Correspondent Contact May Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/12/2021
Decision Date 12/14/2021
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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