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

    Exofin Precision Pen

    K Number: K212246 · Decision Sep 9, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    52

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    Basic Information

    Device Name
    Exofin Precision Pen
    K Number
    K212246
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemence Medical, Inc.
    Date Received
    July 19, 2021
    Decision Date
    September 9, 2021
    Product Code
    MPN
    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
    MPN Tissue Adhesive For The Topical Approximation Of Skin

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    Other Clearances by Chemence Medical, Inc.

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    K162352 derma+flex QS High Viscosity Tissue Adhesive
    K050757 FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE