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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 K211832
Device Name Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
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 09/08/2021
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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