Surgical Face Mask, Surgical Mask

Mask, Surgical

Lear Corporation

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

Pre-market Notification Details

Device IDK201844
510k NumberK201844
Device Name:Surgical Face Mask, Surgical Mask
ClassificationMask, Surgical
Applicant Lear Corporation 1 Penn Dye St Pine Grove,  PA  17963
ContactRyan Facer
CorrespondentRyan Facer
Lear Corporation 1 Penn Dye St Pine Grove,  PA  17963
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2021-07-14

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