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510(k) Data Aggregation
K Number
K021565Device Name
LUTHER SAFETY HUBER NEEDLE SET
Manufacturer
LUTHER RESEARCH PARTNERS
Date Cleared
2002-11-14
(185 days)
Product Code
FPA, REG
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LUTHER RESEARCH PARTNERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
Device Description
The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials. The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.
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