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510(k) Data Aggregation
K Number
K160575Device Name
CareSens Pen Needle, Softip Pen Needle
Manufacturer
Date Cleared
2016-09-07
(190 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
YIDOBIO INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CareSens Pen Needle and Softip Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
Device Description
CareSens Pen Needle and Softip Pen Needle are sterile, non-pyrogenic, single-use injection needles intended for use with injection pens. This needle is a device for subcutaneous injection of medicines such as insulin and exenatide used with pen injectors for subcutaneous injection. CareSens Pen Needle and Softip Pen Needle are the same product in exception to the brand name.
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