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510(k) Data Aggregation
K Number
K182765Device Name
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
Manufacturer
Date Cleared
2019-09-03
(340 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
TOP Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Top NRFit Lock Tip and Slip Tip LOR Syringes and the Additive Slip Tip Syringe are intended to be used with the ISO 80369-6 NRFit neuraxial compliant epidural needles for locating the epidural space, for local administration, and regional administration excluding subarachnoid/spinal block.
Device Description
The TOP NRFit™ Tip Syringes are provided sterile. They are single use devices consisting of rigid USP 2 glass plungers and glass barrels with metal slip tips designed as the ISO 80369 - 6 compliant neuraxial connector which allows 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 (milliliters) indicating the volume of liquid inside the syringe barrel.
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