BRS Level 1 Face Mask, BRS Level 2 Face Mask

Mask, Surgical

Blackbriar Regulatory Services, LLC

The following data is part of a premarket notification filed by Blackbriar Regulatory Services, Llc with the FDA for Brs Level 1 Face Mask, Brs Level 2 Face Mask.

Pre-market Notification Details

Device IDK202824
510k NumberK202824
Device Name:BRS Level 1 Face Mask, BRS Level 2 Face Mask
ClassificationMask, Surgical
Applicant Blackbriar Regulatory Services, LLC 820 Southlake Boulevard Richmond,  VA  23236
ContactVincent Angelico
CorrespondentVincent Angelico
Blackbriar Regulatory Services, LLC 820 Southlake Boulevard Richmond,  VA  23236
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-24
Decision Date2021-03-25

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