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510(k) Data Aggregation
K Number
K063466Device Name
TOP FINE
Manufacturer
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
Date Cleared
2007-03-02
(106 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Device Description
Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which holds the needle. Blister papers the cap. The sterile cap maintains sterility the 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 screwed onto the pen. The needle cap cover is intended to provide physical protection to the needle tube. The device is for single patient single time use. The pens come in three sizes, 29 gauge, 30 gauge, and 31 gauge. They are ETO sterilized, non toxic and nonpyrogenic.
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K Number
K063348Device Name
TOP FINE INSULIN SYRINGE
Manufacturer
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
Date Cleared
2007-03-01
(115 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.
Device Description
Top Fine® 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 0.3 ml/cc, 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. Rx only. The devices operate on the principles of common piston syringes.
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