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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 K203152
Device Name Disposable Face Mask
Applicant
Chaozhou Cecilia Technology Co., Ltd.
Nanyuan Bldg. A, Xiakeng, Yintan, Wenci,
Chaozhou, Guangdong, China
Chaozhou,  CN 515658
Applicant Contact Weng Yu
Correspondent
Imd Medical & Drug Technology Service Institutions
Tianbao Office Rm. 225,Sha Tai Rd. #209
Shenzhen City,  CN 518117
Correspondent Contact Salon Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/22/2020
Decision Date 08/11/2021
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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