BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASP-UI, PAL Aspiration Pump Console

    Reg #: 3014903258 · FEI: 3014903258 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PIVOT - EDM
    Registration Number
    3014903258
    FEI Number
    3014903258
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12202 Cary Circle
    City
    La Vista
    State
    NE
    ZIP
    68128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242804

    Owner / Operator

    Firm Name
    Pivot - EDM
    Operator Number
    10061153
    Address
    12202 Cary Circle
    City
    La Vista
    State
    NE
    Postal Code
    68128
    Country
    US

    Products

    Device Name Product Code
    System, Suction, Lipoplasty For Removal QPB

    Proprietary Names

    ASP-UI, PAL Aspiration Pump Console ASP-PUMP-240, PAL Aspiration Pump, 230V ASP-PUMP-120, PAL Aspiration Pump, 115V

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility