PointCore Surgical Mask

Mask, Surgical

PointCore, Inc.

The following data is part of a premarket notification filed by Pointcore, Inc. with the FDA for Pointcore Surgical Mask.

Pre-market Notification Details

Device IDK220944
510k NumberK220944
Device Name:PointCore Surgical Mask
ClassificationMask, Surgical
Applicant PointCore, Inc. 124 SW Adams Peoria,  IL  61602
ContactWilliam Christiansen
CorrespondentDave McGurl
MCRA, LLC 803 7th Street, NW, 3rd Floor Washington,  DC  20001
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-09-09

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