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

    NON WETTING UNDERCAST PADDING

    K Number: K833732 · Decision Dec 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    239
    Registration Numbers
    239
    Same Product Code
    36
    Applicant Total
    33
    Review Days
    48

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    Basic Information

    Device Name
    NON WETTING UNDERCAST PADDING
    K Number
    K833732
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    American Medical Disposable, Inc.
    Date Received
    October 25, 1983
    Decision Date
    December 12, 1983
    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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    Other Clearances by American Medical Disposable, Inc.

    K Number Device Name
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    K833731 BREATHABLE OVERWRAY BANDAGE NON-ELAS
    K833729 ELASTIC BREATHABLE OVER-WRAP BANDAGE
    K833733 NON - ADHERENT BANDAGE
    K830201 POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
    K830202 COTTON BALLS, X-RAY OPAQUED STRUNG & NON
    K803116 HEAVY DRAINAGE PACK
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