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510(k) Data Aggregation

    K Number
    K990930
    Device Name
    3D ANATOMICAL MESH
    Manufacturer
    SANTERRA MEDICAL TECHNOLOGY, INC.
    Date Cleared
    1999-06-17

    (90 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANTERRA MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use of 3D Anatomical™ Mesh are: - l) inguinal hernia repair - 2) ventral abdominal wall hernia repair
    Device Description
    3D Anatomical™ Mesh is manufactured in a class 10,000 clean room environment in accordance with ISO 9001 and EN 46001 regulations. Full traceability will be maintained on all production lots.
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