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510(k) Data Aggregation
K Number
K211440Device Name
ASM-301 Level 3 Surgical Mask
Manufacturer
Date Cleared
2021-06-02
(23 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
American Surgical Mask Company LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile
Device Description
ASM-301 Level 3 Surgical Mask
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