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510(k) Data Aggregation

    K Number
    K050656
    Date Cleared
    2005-05-02

    (49 days)

    Product Code
    Regulation Number
    878.4800
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMSINO SUTURE REMOVAL KIT

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

    The AMSINO® Suture Removal Kit is intended for use in suture removal procedures.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter acknowledging receipt of a 510(k) premarket notification for the AMSINO® Suture Removal Kit. It does not contain information about acceptance criteria or a study proving device performance. Therefore, I cannot provide the requested details.

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