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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 K203775
Device Name AIC disposable medical mask
Applicant
The Aleen International Corporation
Jiutian Green Science And Technology Industrial Park,
Heyuan High-Tech Zone
Heyuan,  CN 517000
Applicant Contact Can Huang
Correspondent
Duocare, LLC
370 W. Grand Blvd.
Suite 110
Corona,  CA  92882
Correspondent Contact Diana Lam
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/28/2020
Decision Date 03/12/2021
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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