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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 K182514
Device Name Surgical Face Mask
Applicant
Xiantao Zhibo Non-woven Products Co., Ltd
NO.8 in Industrial Park, Hefeng Road
Xiantao,  CN 430000
Applicant Contact Yao Sanyu
Correspondent
Shanghai Sungo Management Consulting Company Limited
4th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/12/2018
Decision Date 01/24/2019
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
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