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

    CREAT BRAND MALAR IMPLANT

    K Number: K873434 · Decision Sep 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    16

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    Basic Information

    Device Name
    CREAT BRAND MALAR IMPLANT
    K Number
    K873434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Aesthetech Corp.
    Date Received
    August 26, 1987
    Decision Date
    September 11, 1987
    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 Aesthetech Corp.

    K Number Device Name
    K873940 CREAT BRAND O-RISE GENERAL ASPIRATOR
    K853189 CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
    K843678 CREAT BRAND SKIN EXPANDER
    K841283 DISPOSABLE SUCTION TUBING SET
    K812210 CREAT BRAND WAGNER CHIN IMPLANT