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

    PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS

    K Number: K993794 · Decision Feb 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
    K Number
    K993794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Playtime Products, Inc.
    Date Received
    November 9, 1999
    Decision Date
    February 7, 2000
    Product Code
    HEB
    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
    HEB Tampon, Menstrual, Unscented

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    Other Clearances by Playtime Products, Inc.

    K Number Device Name
    K981760 PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
    K964269 PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
    K961456 PLAYTEX TAMPONS #10296
    K952394 PLAYTEX TAMPONS #13695
    K950928 ULTIMATES SILK GLIDE TAMPONS
    K923375 PLAYSKOOL SUNGLASSES
    K923374 VARIOUS SUNGLASSES