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

    CIRCULON SYSTEM STEP 2

    K Number: K951021 · Decision Jun 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    23
    Applicant Total
    81
    Review Days
    97

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    Basic Information

    Device Name
    CIRCULON SYSTEM STEP 2
    K Number
    K951021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    March 7, 1995
    Decision Date
    June 12, 1995
    Product Code
    MCY
    Advisory Committee
    General Hospital
    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
    MCY Wound Dressing Kit

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