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

    84E SERIES SINGLE PLY WRAPPER

    K Number: K102864 · Decision Jan 14, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    6
    Review Days
    106

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    Basic Information

    Device Name
    84E SERIES SINGLE PLY WRAPPER
    K Number
    K102864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lac Mac, Ltd.
    Date Received
    September 30, 2010
    Decision Date
    January 14, 2011
    Product Code
    FRG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRG Wrap, Sterilization

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