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

    STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510

    K Number: K921613 · Decision Jan 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    5
    Review Days
    298

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    Basic Information

    Device Name
    STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510
    K Number
    K921613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dept. of the Army
    Date Received
    April 6, 1992
    Decision Date
    January 29, 1993
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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