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510(k) Data Aggregation
K Number
K203211Device Name
Insulin syringe with integrated needle DL
Manufacturer
Date Cleared
2023-02-09
(832 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
DLP Medical Products, Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable syringe for insulin administration, for the patient with diabetes.
Device Description
Insulin syringe with integrated extra thin stainless-steel needle and dead space less than 0.005 ml, made of medical grade plastic, sterile, disposable, pyrogen free and non-toxic. Sterilized by ethylene oxide. The product is composed of the following parts: Cylinder or barrel, Piston, Plunger, Needle, Needle cover or protector.
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