BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMPRESS AND SKULLCAP, HEAD DRESSING

    K Number: K870240 · Decision Feb 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    8
    Applicant Total
    23
    Review Days
    30

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    Basic Information

    Device Name
    COMPRESS AND SKULLCAP, HEAD DRESSING
    K Number
    K870240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Fraass Survival Systems, Inc.
    Date Received
    January 21, 1987
    Decision Date
    February 20, 1987
    Product Code
    EXR
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EXR Urinometer, Mechanical

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    Other Clearances by Fraass Survival Systems, Inc.

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    K871376 FIRST AID KIT, VARIOUS SIZES
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    K871457 FIRST AID KIT, EYE DRESSING
    K871438 BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
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