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510(k) Data Aggregation
K Number
K221777Device Name
Disposable Sterile Syringe
Manufacturer
Date Cleared
2023-10-06
(472 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Weihai Shengjie Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable Sterile Syringe is intended to inject fluids into or withdraw fluids from the body.
Device Description
Disposable Sterile Syringe, is a plastic syringe designed for intended to inject fluids into or withdraw fluids from the body. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a barrel, plunger, Piston, Needle tube, Needle hub and Needle cap.
All specifications of product subject to the same design and the difference between each specification is syringe volume and needle size. The product is available in a variety combination of needle size and syringe volume.
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