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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.
#5 Xinghe Rd., Nanjing Economic And Technological
Development Zone
Nanjing,  CN 210038
Applicant Contact Bob Bao
Correspondent
Amphastar Nanjing Pharmaceuticals, Inc.
#5 Xinghe Rd., 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
Predetermined Change
Control Plan Authorized		 No
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