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

    PROFILE SWAB CAT.#5273 & 5274

    K Number: K802004 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    279
    Registration Numbers
    279
    Same Product Code
    0
    Applicant Total
    31
    Review Days
    27

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    Basic Information

    Device Name
    PROFILE SWAB CAT.#5273 & 5274
    K Number
    K802004
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pollak (Intl.), Ltd.
    Date Received
    August 20, 1980
    Decision Date
    September 16, 1980
    Product Code
    KXG
    Advisory Committee
    General Hospital
    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
    KXG Applicator, Absorbent Tipped, Sterile

    Other Clearances by Pollak (Intl.), Ltd.

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    K802011 INFUSSION ALARM SYSTEM I.A.S. CAT.#1118
    K802017 DRESSING CHANGE SET CAT.#910-930
    K802007 PEDIWET=GUAZE IMPREGNATED WITH PETROL
    K801991 PLASTIC FORCEPS CAT.#1001-1010
    K801996 GUAZE BANDAGES CAT.#101-169
    K802021 PEDIBAND CAT.#195-197
    Search all 31 clearances from Pollak (Intl.), Ltd. →