DemeMASK

Mask, Surgical

DemeTECH Corporation

The following data is part of a premarket notification filed by Demetech Corporation with the FDA for Dememask.

Pre-market Notification Details

Device IDK201479
510k NumberK201479
Device Name:DemeMASK
ClassificationMask, Surgical
Applicant DemeTECH Corporation 14175 NW 60th Avenue Miami Lakes,  FL  33014
ContactTracy Chadwrick
CorrespondentTracy Chadwrick
DemeTECH Corporation 14175 NW 60th Avenue Miami Lakes,  FL  33014
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2020-07-24

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