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

    SEARE BIOMEDICAL SILICONE BLOCK

    K Number: K983043 · Decision Sep 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    30

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    Basic Information

    Device Name
    SEARE BIOMEDICAL SILICONE BLOCK
    K Number
    K983043
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seare Biomedical Corp.
    Date Received
    August 31, 1998
    Decision Date
    September 30, 1998
    Product Code
    MIC
    Advisory Committee
    Ear, Nose, Throat
    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
    MIC Implant, Muscle, Pectoralis

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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
    K982752 SEARE BIOMEDICAL CHIN IMPLANTS
    K982762 SEARE BIOMEDICAL PECTORALIS IMPLANT
    K982753 SEARE BIOMEDICAL NASAL IMPLANTS
    K982763 SEARE BIOMEDICAL MALAR IMPLANTS
    K983041 SEARE BIOMEDICAL SILICONE SHEETING