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510(k) Data Aggregation
K Number
K110606Device Name
MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE
Manufacturer
M.V. S.R.L.
Date Cleared
2011-09-29
(210 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
M.V. S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MV intradermic needles are intended to inject fluids intradermally.
Device Description
The device is comprised of a metal tube. On one end the tip is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.
The MV intradermic needle is marketed alone or combined with a pilot needle. The pilot needle is an hypodermic single lumen needle intended to prepare the site for injection. The tip of the pilot needle is sharpened at one end, while the other end is joined to a hub. The pilot needle can be any traditional legally marketed hypodermic needle.
The MV intradermic needles are single-use devices sold as sterile.
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