BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SyvekExcel Bandage

    Reg #: 3008546445 · FEI: 3008546445 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.
    Registration Number
    3008546445
    FEI Number
    3008546445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    25 Commerce Dr
    City
    Bedford
    State
    NH
    ZIP
    03110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082703

    Owner / Operator

    Firm Name
    Lyophilization Services of New England, Inc.
    Operator Number
    9031362
    Address
    25 Commerce Drive, --
    City
    Bedford
    State
    NH
    Postal Code
    03110
    Country
    US
    Correspondent
    Shawn - Cain

    Products

    Device Name Product Code
    Bandage, Liquid KMF

    Proprietary Names

    SyvekExcel Bandage

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)