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

    PLAYTEX BREAST PUMP

    K Number: K022594 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    17
    Review Days
    88

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    Basic Information

    Device Name
    PLAYTEX BREAST PUMP
    K Number
    K022594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Playtex Products, Inc.
    Date Received
    August 5, 2002
    Decision Date
    November 1, 2002
    Product Code
    HGX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGX Pump, Breast, Powered

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    Other Clearances by Playtex Products, Inc.

    K Number Device Name
    K073662 PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
    K072376 PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
    K070745 MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
    K061013 PLAYTEX EMBRACE PETITE BREAST PUMP
    K060981 PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
    K032636 PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
    K022882 MODIFICATION TO PLAYTEX TAMPONS #24002
    K020200 PLAYTEX DEODORANT TAMPONS, MODEL 34802
    K020201 PLAYTEX DEODORANT TAMPONS, MODEL 34902
    K020202 PLAYTEX DEODORANT TAMPONS, MODEL 34702
    Search all 17 clearances from Playtex Products, Inc. →