ClearMask Transparent Surgical Face Mask

Mask, Surgical

ClearMask, LLC

The following data is part of a premarket notification filed by Clearmask, Llc with the FDA for Clearmask Transparent Surgical Face Mask.

Pre-market Notification Details

Device IDK200576
510k NumberK200576
Device Name:ClearMask Transparent Surgical Face Mask
ClassificationMask, Surgical
Applicant ClearMask, LLC 900 E. Fayette St., PO Box 22493 Baltimore,  MD  21203
ContactAaron Hsu
CorrespondentAaron Hsu
ClearMask, LLC 900 E. Fayette St., PO Box 22493 Baltimore,  MD  21203
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2020-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10860005106025 K200576 000

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