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

    derma+flex QS High Viscosity Tissue Adhesive

    K Number: K162352 · Decision Dec 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    121

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    Basic Information

    Device Name
    derma+flex QS High Viscosity Tissue Adhesive
    K Number
    K162352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemence Medical, Inc.
    Date Received
    August 23, 2016
    Decision Date
    December 22, 2016
    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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