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510(k) Data Aggregation
K Number
K092831Device Name
DISPOSABLE HYPODERMIC NEEDLE
Manufacturer
FEEL TECH
Date Cleared
2010-01-14
(121 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
FEEL TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Device Description
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. . The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) The needle cap covers intended to provide physical protection to the needle tube.
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K Number
K080904Device Name
FEEL-FINE INSULIN PEN NEEDLE
Manufacturer
FEEL TECH
Date Cleared
2008-06-04
(64 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
FEEL TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Device Description
Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
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K Number
K070917Device Name
FEEL-JECT INSULIN SYRINGE
Manufacturer
FEEL TECH
Date Cleared
2007-06-20
(79 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
FEEL TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Feel-tech disposable sterile insulin syringes are intended for injection of U100 insulin only.
Device Description
The Feel-ject insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
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