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

    PRE-PADDED PLASTER/PARIS BAND/SPLINTS

    K Number: K800752 · Decision Apr 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    239
    Registration Numbers
    239
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    17

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    Basic Information

    Device Name
    PRE-PADDED PLASTER/PARIS BAND/SPLINTS
    K Number
    K800752
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Ortho-Care, Inc.
    Date Received
    April 4, 1980
    Decision Date
    April 21, 1980
    Product Code
    ITG
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITG Bandage, Cast

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