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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 K211827
Device Name Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
Applicant
Zhejiang Lanhine Medical Products, Ltd.
1989 Cidong Rd., Cidongbinhai District
Cixi,  CN 315300
Applicant Contact Jerry Gu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/14/2021
Decision Date 09/23/2021
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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