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510(k) Data Aggregation

    K Number
    K092284
    Device Name
    LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
    Manufacturer
    MEDICAL DEVICE RESOURCE CORP.
    Date Cleared
    2009-09-01

    (34 days)

    Product Code
    MUU, KYZ
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE RESOURCE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in aspirating subcutaneous fatty tissue including autologous fat collection.
    Device Description
    Device function: 1. Contains port interfaces between: Canister to tubing & aspirator to canister. 2. Sterile tubing to connect the interfaces 3. Funnel to interface port to tubing. 4. Syringe to collect fat. Device design: 1. Contents subjected to sterility Material used: Plastic Canister, Syringe, silicone tubing Physical properties: Plastic & Silicone
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    K Number
    K081593
    Device Name
    POWER ASPIRATOR, MODEL LS2 OR LS2DP
    Manufacturer
    MEDICAL DEVICE RESOURCE CORP.
    Date Cleared
    2008-07-23

    (47 days)

    Product Code
    QPB, MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DEVICE RESOURCE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LS Liposuction Aspirator is for aesthetic body contouring.
    Device Description
    The LS Liposuction Aspirator is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/ adipose (Suction Lipoplasty), soft tissue, and general surgical waste.
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