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

    PEDIA PALS, INCORPORATED

    K Number: K950086 · Decision Feb 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    11
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    PEDIA PALS, INCORPORATED
    K Number
    K950086
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.1800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pedia Pals, Inc.
    Date Received
    January 10, 1995
    Decision Date
    February 7, 1995
    Product Code
    EPY
    Advisory Committee
    General, Plastic Surgery
    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
    EPY Speculum, Ent

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    Other Clearances by Pedia Pals, Inc.

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    K951041 BLOOD PRESSURE CUFF 3
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