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510(k) Data Aggregation

    K Number
    K024372
    Device Name
    CP MEDICAL BONE WAX
    Manufacturer
    CP MEDICAL
    Date Cleared
    2003-06-19

    (170 days)

    Product Code
    MTJ
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K791495,K971680
    Why did this record match?
    Device Name :

    CP MEDICAL BONE WAX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CP Medical Bone Wax is indicated for use in the control of bleeding from bone surfaces.

    Device Description

    The proposed device is composed of a beeswax and paraffin formulation.
    The proposed device is manufactured in compliance with cGMP and ISO quality standards.

    AI/ML Overview

    This submission K024372 is for a medical device (Bone Wax) and does not contain information related to AI/ML software. Therefore, none of the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is applicable or available in the provided text. The submission focuses on substantial equivalence to predicate devices based on composition and manufacturing standards, not on performance metrics of an AI algorithm.

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