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510(k) Data Aggregation

    K Number
    K000849
    Device Name
    SOFTFORM FACIAL IMPLANT
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    2000-05-19

    (65 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K013625
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K973462
    Device Name
    SOFTFORM FACIAL IMPLANT
    Manufacturer
    TISSUE TECHNOLOGIES, INC.
    Date Cleared
    1997-11-24

    (73 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K013625
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For Plastic and Reconstructive Surgery*
    Prescription Use (Per 21 CFR 801.109)

    • This product is available by prescription only.
    Device Description

    SoftForm™ Implant

    AI/ML Overview

    I apologize, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for a device called "SoftForm™ Implant." It does not include acceptance criteria, study details, or performance data for the device. The letter simply states that the FDA has determined the device to be substantially equivalent to previously marketed devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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