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510(k) Data Aggregation

    K Number
    K073705
    Device Name
    MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE
    Manufacturer
    SHANDONG QIAOPAI GROUP CO., LTD
    Date Cleared
    2008-03-24

    (84 days)

    Product Code
    FMI,FOZ
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
    Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for a medical device called "Scalp Vein Set for Single Use Sterile Hypodermic Needles for Single Use." It does not contain information about acceptance criteria or a study proving device performance as requested. All the information in the provided text relates to regulatory approval, product codes, and indications for use, not performance studies. Therefore, I cannot generate the requested table and study information from the given input.

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