BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGIFORM ANATOMICAL MALAR

    K Number: K964443 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    12
    Review Days
    44

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    Basic Information

    Device Name
    SURGIFORM ANATOMICAL MALAR
    K Number
    K964443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Technology Laboratories, Inc.
    Date Received
    November 6, 1996
    Decision Date
    December 20, 1996
    Product Code
    LZK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZK Implant, Malar

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    Other Clearances by Surgical Technology Laboratories, Inc.

    K Number Device Name
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    K840835 STRAITH DRAIN INSERTER
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    K801072 STRAITH NASAL SPLINT
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