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510(k) Data Aggregation
K Number
K052667Device Name
ARTSANA PISTON AND INSULIN SYRINGES
Manufacturer
ARTSANA S.P.A.
Date Cleared
2005-11-25
(59 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ARTSANA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artsana disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
Device Description
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K Number
K051783Device Name
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES
Manufacturer
ARTSANA S.P.A.
Date Cleared
2005-10-04
(95 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
ARTSANA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
Device Description
Not Found
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