BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILE ESMARCH BANDAGE

    K Number: K881176 · Decision Apr 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    335
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    24

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    Basic Information

    Device Name
    STERILE ESMARCH BANDAGE
    K Number
    K881176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Spectrum/Hydro-Med Products, Inc.
    Date Received
    March 18, 1988
    Decision Date
    April 11, 1988
    Product Code
    GAX
    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
    GAX Tourniquet, Nonpneumatic

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