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

    CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063

    K Number: K050998 · Decision Jun 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
    K Number
    K050998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Confluent Surgical,Inc
    Date Received
    April 20, 2005
    Decision Date
    June 15, 2005
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    K070814 MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
    K061183 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
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