BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ExSept Plus

    Reg #: 3001239013 · FEI: 3001239013 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ANGELINI PHARMA INC.
    Registration Number
    3001239013
    FEI Number
    3001239013
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    230 Peachtree Street NW, Suite 1250
    City
    ATL
    State
    GA
    ZIP
    30303
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082858

    Owner / Operator

    Firm Name
    Angelini Pharma Inc.
    Operator Number
    10027838
    Address
    230 Peachtree Street NW, Suite 1250
    City
    ATL
    State
    GA
    Postal Code
    30303
    Country
    US
    Correspondent
    Mavis K Gyaase

    Products

    Device Name Product Code
    Lavage, Jet FQH

    Proprietary Names

    ExSept Plus Amekina® Skin and wound Spray

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility