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

    FOAM RING PORT PROTECTOR

    K Number: K062261 · Decision Apr 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    248

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    Basic Information

    Device Name
    FOAM RING PORT PROTECTOR
    K Number
    K062261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inspired Ideas, Incorporated
    Date Received
    August 4, 2006
    Decision Date
    April 9, 2007
    Product Code
    OBK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBK Port, Protector/Cushion