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

    ADIPREP ADIPOSE TRANSFER SYSTEM

    K Number: K121005 · Decision Sep 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    171

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    Basic Information

    Device Name
    ADIPREP ADIPOSE TRANSFER SYSTEM
    K Number
    K121005
    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
    Harvest Technologies, Corp.
    Date Received
    April 3, 2012
    Decision Date
    September 21, 2012
    Product Code
    MUU
    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
    MUU System, Suction, Lipoplasty

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