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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 K203426
Device Name Surgical Face Mask (non-sterile)
Applicant
Nantong Taiweishi Medical Technology Co., Ltd.
Taihangshan Rd., New District, Economic Development Zone,
Rudong County
Nantong,  CN 226400
Applicant Contact Zhang Xuewen
Correspondent
Shanghai Sungo Management Consulting Company Limited.
13th Floor, 1500# Central Ave.
Shangghai,  CN 200122
Correspondent Contact Mandy Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/20/2020
Decision Date 02/18/2021
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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