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

    CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)

    K Number: K965059 · Decision Mar 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    9
    Review Days
    76

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    Basic Information

    Device Name
    CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
    K Number
    K965059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thomas Industries
    Date Received
    December 18, 1996
    Decision Date
    March 4, 1997
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Thomas Industries

    K Number Device Name
    K041199 MEDI-PUMP ASPIRATOR, MODEL 1615
    K952806 MEDI PUMP ASPIRATOR MODELS 1130 AND 1135
    K950290 MEDI - PUMP
    K951729 MEDI - PUMP
    K950867 MEDI - PUMP
    K944399 MEDI-PUMP
    K925010 NEBULIZER PUMP, POWERED, MODEL 1110
    K925011 NEBULIZER PUMP, POWERED MODEL 1180