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

    SPECTRUM DESIGNS SILICONE BLOCK

    K Number: K960038 · Decision Mar 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    18
    Review Days
    70

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    Basic Information

    Device Name
    SPECTRUM DESIGNS SILICONE BLOCK
    K Number
    K960038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spectrum Designs, Inc.
    Date Received
    January 3, 1996
    Decision Date
    March 13, 1996
    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 Spectrum Designs, Inc.

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    K980446 SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
    K980444 SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
    K980463 SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
    K980445 SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
    K980138 SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
    K980461 SPECTRUM DESIGNS CLEFT CHIN IMPLANT
    K980141 SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
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