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510(k) Data Aggregation
K Number
K152824Device Name
MEDT PEN NEEDLE
Manufacturer
SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD.
Date Cleared
2016-03-07
(160 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEDT Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Device Description
The proposed device, MEDT Pen Needle, is a single-use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of three components, which are (1) needle, (2) hub and (3) inner sheath; it is sealed in a package consists of (1) a outer sheath and (2) Tyvek Paper.
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