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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 K210767
Device Name Surgical Masks, Model:FE-1
Applicant
Hunan Triplex Precision Medical Devices Co., Ltd.
Rm. 612 & 613, Bldg. #5~8, Sunvo Health & Medicine
Industrial Park,
Changsha,  CN 410153
Applicant Contact Huang Kai
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 703, 705, Bldg. 1, W. Guangzhong Rd. 555,
Shanghai,  CN 200072
Correspondent Contact Amber Pang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/15/2021
Decision Date 06/10/2021
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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