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510(k) Data Aggregation
K Number
K171131Device Name
MHC Standard and NRFit Tip Syringes
Manufacturer
Date Cleared
2017-11-08
(205 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Mazza Healthcare, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MHC Standard and NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.
Device Description
The MHC Standard and NRFit™ Tip Syringes are provided sterile or in bulk non-sterile for further processing (e.g., sterilization). They are single use devices consisting of rigid polycarbonate barrels and plungers with a synthetic rubber gasket. The syringe barrels with neuraxial tips are ISO 80369 - 6 compliant and allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (millliters) indicating the volume of liquid inside the syringe barrel.
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