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510(k) Data Aggregation
K Number
K990331Device Name
SURGEN VALVE
Manufacturer
Date Cleared
2000-05-31
(484 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TIVA MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Continuous or intermittent multiple access connection port between IV devices such as patient access sites, catheters, syringes, or IV administrations sets.
The sharps injury prevention feature of this device is the need for a needle. The device (valve) is activated by inserting a standard male luer on the end of marketed I.V. administration sets and syringes into the proximal end of the SurgeN.
Device Description
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