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K Number
K954718
Device Name
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1996-02-29

(139 days)

Product Code
HEE
Regulation Number
884.5100
Type
Traditional
Panel
Obstetrics/Gynecology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.5100 Obstetric anesthesia set.

(a)
Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.(b)
Classification. Class II (performance standards).