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K Number
K010377
Device Name
MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
Manufacturer
MINIMED, INC.
Date Cleared
2001-04-05

(56 days)

Product Code
KZH
Regulation Number
880.6920
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).