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510(k) Data Aggregation
K Number
K133058Device Name
INSULIN PEN NEEDLE
Manufacturer
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
Date Cleared
2014-02-25
(151 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
**WENZHOU WUZHOU IMPORT **& EXPORT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Device Description
The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
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K Number
K110421Device Name
DISPOSABLE INSULIN SYRINGE
Manufacturer
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
Date Cleared
2011-04-26
(71 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
**WENZHOU WUZHOU IMPORT **& EXPORT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable insulin syringe is a device intended for medical purpose for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
Device Description
Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The proposed device of Disposable Insulin Syringe is a syringe with needle, consisting of a calibrated hollow barrel, a movable plunger, the needle cover and end cap. The needle is fixed on the syringe. The syringe is designed for manual use.
The proposed device of Disposable Insulin Syringe is available in 0.3ml (U-100), 0.5ml (U-40, U-100), 1ml (U-40, U-100) volumes.
The proposed device is provided sterilized.
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