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

    POROUS, BREATHING TAPE W/RELEASE LINER

    K Number: K802752 · Decision Dec 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    934
    Registration Numbers
    934
    Same Product Code
    183
    Applicant Total
    1
    Review Days
    37

    Basic Information

    Device Name
    POROUS, BREATHING TAPE W/RELEASE LINER
    K Number
    K802752
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    BIOADHESIVE SYSTEMS, INC.
    Date Received
    November 3, 1980
    Decision Date
    December 10, 1980
    Product Code
    KGX
    Advisory Committee
    General Hospital
    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
    KGX Tape And Bandage, Adhesive

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