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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 K201545
Device Name Surgical Face Mask
Applicant
Amphastar Nanjing Pharmaceuticals, Inc.
No.5 Xinghe Road, Nanjing Economic and Technological
Development Zone
Nanjing,  CN 210038
Applicant Contact Bob Bao
Correspondent
Amphastar Nanjing Pharmaceuticals, Inc.
No.5 Xinghe Road, Nanjing Economic and Technological
Development Zone
Nanjing,  CN 210038
Correspondent Contact Bob Bao
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/09/2020
Decision Date 02/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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