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K Number
K001129
Device Name
PROLONG, MODELS PL50, PL100, PL150
Manufacturer
LIFE-TECH INTL., INC.
Date Cleared
2000-07-06

(90 days)

Product Code
CAZ
Regulation Number
868.5140
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5140 Anesthesia conduction kit.

(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).