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510(k) Data Aggregation
K Number
K092746Device Name
MICRONJET 600
Manufacturer
Date Cleared
2010-02-03
(148 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
NANOPASS TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MicronJet 600 is intended to be used for injecting fluids into parts of the body below the surface of the skin. The MicronJet 600 is indicated for use in intradermal injections of any substance or drug approved for intradermal delivery.
Device Description
The MicronJet 600 Needle is a small plastic adapter (female luer) equipped with a chip having three microneedles designed to mate with any standard syringe (Luer Slip or Luer Lock). The MicronJet 600 is a sterile, single use device.
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