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

    SELF-SEAL STERILIZATION POUCHES

    K Number: K832128 · Decision Aug 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    SELF-SEAL STERILIZATION POUCHES
    K Number
    K832128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medical Industries Packaging, Inc.
    Date Received
    July 1, 1983
    Decision Date
    August 8, 1983
    Product Code
    KCT
    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
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Medical Industries Packaging, Inc.

    K Number Device Name
    K831165 DUSTCOVERS/STERILITY MAINTENANCE COVERS
    K830961 EASY BREATHER HEADER BAGS
    K821331 MEDI-SEAL STERILIZATION POUCHES & TUB
    K821330 GAS STERILIZATION POUCHES
    K821332 DUSTCOVERS &/OR STERILITY MAINT. COVERS