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

    STERILE WET DRESSING PACK

    K Number: K834532 · Decision Jan 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    330
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    STERILE WET DRESSING PACK
    K Number
    K834532
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    W.G. Whitney Corp.
    Date Received
    December 21, 1983
    Decision Date
    January 25, 1984
    Product Code
    KDD
    Advisory Committee
    General, Plastic Surgery
    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
    KDD Kit, Surgical Instrument, Disposable

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    Other Clearances by W.G. Whitney Corp.

    K Number Device Name
    K813535 XEROFORM DRESSING
    K810406 STERILE WET DRESSING PACK
    K803299 COLD/HOT PACK
    K800907 TOMAC WET DRESSING WARMER
    K781322 STERILE WET DRESSING PACK
    K770387 UNICATCH