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510(k) Data Aggregation
K Number
K212949Device Name
Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use
Manufacturer
Date Cleared
2022-02-24
(161 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Henan Nursecare Biotechnology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sterile Syringe with Safety needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Sterile Syringe with needle for Single Use is intended for use in the aspiration of fluids for medical purpose.
Sterile Syringe for Single Use is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Safety Needle for Single Use is intended to be used with a luer slip syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
Sterile Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.
Device Description
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