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

    REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.

    K Number: K882684 · Decision Aug 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    23
    Review Days
    34

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    Basic Information

    Device Name
    REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
    K Number
    K882684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Standard Textile Co., Inc.
    Date Received
    June 30, 1988
    Decision Date
    August 3, 1988
    Product Code
    LRO
    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
    LRO General Surgery Tray

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