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510(k) Data Aggregation
K Number
K093901Device Name
SURGICAL FACE MASK
Manufacturer
Date Cleared
2010-09-10
(262 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
EPARD PROTECTIVE PRODUCTS, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Device Description
Surgical Face Mask ear loop yellow, Surgical Face Mask ear loop blue, Surgical Face Mask tie-on yellow, and Surgical Face Mask tie-on blue
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