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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 K182515
Device Name Surgical Face Mask
Applicant
Wuhan Dymex Healthcare Co., Ltd.
Rm. 1701, Unit 2, Bldg. 5, Jingsegangwan
Phase 5, Dongfeng Avenus
Wuhan,  CN 430000
Applicant Contact Ada Liu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
4th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/12/2018
Decision Date 05/27/2019
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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