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510(k) Data Aggregation
K Number
K211728Device Name
Sterile hypodermic syringes for single use
Manufacturer
Date Cleared
2021-10-05
(123 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Kangyou Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sterile hypodermic syringes for single use are intended to inject fluids into or withdraw fluids from the body.
Device Description
The Sterile hypodermic syringes for single use are intended for manual and single use only to aspirate and inject of fluids for medical purpose, and consist of syringe (barrel, plunger, piston) and hypodermic needle (needle tube, hub, needle cap). The proposed device is available in a variety of syringe and needle sizes.
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