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

    PLAYSKOOL SUNGLASSES

    K Number: K923375 · Decision Jun 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    1390
    Registration Numbers
    1390
    Same Product Code
    645
    Applicant Total
    8
    Review Days
    335

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    Basic Information

    Device Name
    PLAYSKOOL SUNGLASSES
    K Number
    K923375
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Playtime Products, Inc.
    Date Received
    July 9, 1992
    Decision Date
    June 9, 1993
    Product Code
    HQY
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQY Sunglasses (Non-Prescription Including Photosensitive)

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    K964269 PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS
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    K950928 ULTIMATES SILK GLIDE TAMPONS
    K923374 VARIOUS SUNGLASSES