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

    SEARE BIOMEDICAL MALAR IMPLANTS

    K Number: K982763 · Decision Sep 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    8
    Review Days
    55

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    Basic Information

    Device Name
    SEARE BIOMEDICAL MALAR IMPLANTS
    K Number
    K982763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seare Biomedical Corp.
    Date Received
    August 6, 1998
    Decision Date
    September 30, 1998
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LZK), ordered by most recent decision date.

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    SPECTRUM DESIGNS PROJECTION MALAR IMPLANT

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    Other Clearances by Seare Biomedical Corp.

    K Number Device Name
    K983792 SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
    K983630 SEARE BIOMEDICAL SILICONE RODS
    K983043 SEARE BIOMEDICAL SILICONE BLOCK
    K982752 SEARE BIOMEDICAL CHIN IMPLANTS
    K982762 SEARE BIOMEDICAL PECTORALIS IMPLANT
    K982753 SEARE BIOMEDICAL NASAL IMPLANTS
    K983041 SEARE BIOMEDICAL SILICONE SHEETING