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

    SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE

    K Number: K903823 · Decision Jan 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    972
    Registration Numbers
    972
    Same Product Code
    186
    Applicant Total
    15
    Review Days
    149

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    Basic Information

    Device Name
    SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
    K Number
    K903823
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Smith and Nephew Donjoy, Inc.
    Date Received
    August 20, 1990
    Decision Date
    January 16, 1991
    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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