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

    PILLOW W/STAPHCHEK TICKING

    K Number: K842335 · Decision Aug 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    64
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    PILLOW W/STAPHCHEK TICKING
    K Number
    K842335
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6060
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Monterey Mills, Inc.
    Date Received
    June 13, 1984
    Decision Date
    August 1, 1984
    Product Code
    KME
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KME Bedding, Disposable, Medical

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    Other Clearances by Monterey Mills, Inc.

    K Number Device Name
    K842336 DISPOSABLE PILLOW