BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    KELO-COTE TOPICAL GEL

    K Number: K002488 · Decision Jan 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    144

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    Basic Information

    Device Name
    KELO-COTE TOPICAL GEL
    K Number
    K002488
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Bio-Technologies, Inc.
    Date Received
    August 14, 2000
    Decision Date
    January 5, 2001
    Product Code
    MDA
    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
    MDA Elastomer, Silicone, For Scar Management

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    Other Clearances by Advanced Bio-Technologies, Inc.

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