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510(k) Data Aggregation
K Number
K042654Device Name
PROTECTION PLUS EARLOOP PROCEDURE MASK
Manufacturer
SAFETY-MED PRODUCTS, INC.
Date Cleared
2004-12-17
(80 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SAFETY-MED PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Device Description
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