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510(k) Data Aggregation
K Number
K083472Device Name
MEDEGEN PRESSURE RATED EXTENSION SETS
Manufacturer
MEDEGEN INC.
Date Cleared
2008-12-09
(15 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDEGEN INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.
Device Description
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