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510(k) Data Aggregation

    K Number
    K021889
    Device Name
    SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    2002-10-16

    (131 days)

    Product Code
    KKY
    Regulation Number
    878.3500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)

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

    For Plastic and Reconstructive Surgery

    Device Description

    The Surgiform Technology Ltd.'s S.F.A.M. implant is intended for augmentation or repair of the soft tissues of the facial area. The product is available in sheets or strands of the following sizes: Sheets: Length 5-100mm, Width 5-100mm, Thickness 0.2-0.4mm. Strands: 5-15cm, OD-1.0-4.0mm.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, indicating that their device (Surgiform Augmentation Material) has been found substantially equivalent to a legally marketed predicate device.

    This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory approval letter, not a scientific study report. Therefore, I cannot extract the requested information from this text.

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