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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 K201479
Device Name DemeMASK
Applicant
DemeTECH Corporation
14175 NW 60th Avenue
miami lakes,  FL  33014
Applicant Contact tracy chadwrick
Correspondent
DemeTECH Corporation
14175 NW 60th Avenue
miami lakes,  FL  33014
Correspondent Contact tracy chadwrick
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/04/2020
Decision Date 07/24/2020
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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