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510(k) Data Aggregation
K Number
K202824Device Name
BRS Procedure Face Mask
Manufacturer
Date Cleared
2021-03-25
(182 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Blackbriar Regulatory Services, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BRS Procedure Face Mask is a non-sterile, single use, disposable face mask intended to be worn to protect both healthcare personnel and patients from the transfer of microorganisms, blood and body fluids, and particulate material. This equipment is intended for the use in infection control practices to reduce the potential exposure to blood and fluids.
BRS Level 1 Procedure Face Mask (Model# 00850021617004)
BRS Level 2 Procedure Face Mask (Model# 00850021617196)
BRS Level 3 Procedure Face Mask (Model# 00850021617561)
Device Description
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