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

    IQ CHAMBERS

    K Number: K992553 · Decision Apr 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    364
    Registration Numbers
    364
    Same Product Code
    20
    Applicant Total
    1
    Review Days
    257

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    Basic Information

    Device Name
    IQ CHAMBERS
    K Number
    K992553
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6025
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dormer Laboratories, Inc.
    Date Received
    July 30, 1999
    Decision Date
    April 12, 2000
    Product Code
    KXF
    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
    KXF Applicator, Absorbent Tipped, Non-Sterile

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