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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 K200576
Device Name ClearMask Transparent Surgical Face Mask
Applicant
Clearmask, LLC
900 E. Fayette St., P.O. Box 22493
Baltimore,  MD  21203
Applicant Contact Aaron Hsu
Correspondent
Clearmask, LLC
900 E. Fayette St., P.O. Box 22493
Baltimore,  MD  21203
Correspondent Contact Aaron Hsu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/05/2020
Decision Date 04/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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