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510(k) Data Aggregation
K Number
K161255Device Name
meso-relle (AAL34, AAL36, AM30G)
Manufacturer
Date Cleared
2017-01-19
(261 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
BIOTEKNE SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The meso-relle needles are intended to inject fluids intradermally.
Device Description
The meso-relle® needles are single lumen needle intended to inject fluids intradermally. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe. Needles have different length, which make them suitable to inject fluids intradermally. The meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally. Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle. The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide.
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