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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K983754
    Device Name
    STANDARD CHIN
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1998-11-20

    (29 days)

    Product Code
    FWP
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Technology Laboratories, Inc. Standard Chin implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.
    Device Description
    Not Found
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    K Number
    K983755
    Device Name
    NASAL DORSAL SERIES
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1998-11-20

    (29 days)

    Product Code
    FZE
    Regulation Number
    878.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgical Technology Laboratories, Inc. Nasal Dorsal Series implants are intended to be used to augment or reconstruct the nose in rhinoplasty.
    Device Description
    Not Found
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    K Number
    K983756
    Device Name
    SURGIFORM ANATOMICAL MALAR
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1998-11-20

    (29 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Surgiform Anatomical Malar implants can be used by surgeons in a unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial trauma.
    Device Description
    Not Found
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    K Number
    K964443
    Device Name
    SURGIFORM ANATOMICAL MALAR
    Manufacturer
    SURGICAL TECHNOLOGY LABORATORIES, INC.
    Date Cleared
    1996-12-20

    (44 days)

    Product Code
    LZK
    Regulation Number
    878.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL TECHNOLOGY LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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