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

    LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);

    K Number: K053451 · Decision Aug 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    2
    Review Days
    256

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    Basic Information

    Device Name
    LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);
    K Number
    K053451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Moeller Medical GmbH & Co. KG
    Date Received
    December 12, 2005
    Decision Date
    August 25, 2006
    Product Code
    QPB
    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
    QPB System, Suction, Lipoplasty For Removal

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    Other Clearances by Moeller Medical GmbH & Co. KG

    K Number Device Name
    K072793 LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688