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

    SEARE BIOMEDICAL SILICONE RODS

    K Number: K983630 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    57

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    Basic Information

    Device Name
    SEARE BIOMEDICAL SILICONE RODS
    K Number
    K983630
    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
    October 15, 1998
    Decision Date
    December 11, 1998
    Product Code
    MIB
    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
    MIB Elastomer, Silicone Block

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    Other Clearances by Seare Biomedical Corp.

    K Number Device Name
    K983792 SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
    K983043 SEARE BIOMEDICAL SILICONE BLOCK
    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