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510(k) Data Aggregation
K Number
K133059Device Name
INSULIN PEN NEEDLE
Manufacturer
WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD.
Date Cleared
2014-02-25
(151 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
**WENZHOU BEIPU SCIENCE **& TECHNOLOGY 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. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
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