BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Spatz3 Adjustable Balloon System

    Reg #: 3012638928 · FEI: 3015409025 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPATZ FGIA INC.
    Registration Number
    3012638928
    FEI Number
    3015409025
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ha-Tidhar 2
    City
    Ra'anana Central
    Country
    IL

    Regulatory Submissions

    PMA Number
    P190012

    Owner / Operator

    Firm Name
    Spatz FGIA Inc.
    Operator Number
    10083108
    Address
    1801 S Perimeter Road STE 130
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33309
    Country
    US
    Correspondent
    Pnina Polishuk

    US Agent

    Business Name
    Spatz FGIA Inc.
    Contact Name
    David Harris
    Address
    1801 S Perimeter Rd Ste 130
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US
    Email
    [email protected]
    Phone
    703 7395695

    Products

    Device Name Product Code
    Implant, Intragastric For Morbid Obesity LTI

    Proprietary Names

    Spatz3 Adjustable Balloon System

    Establishment Types

    Manufacture Medical Device