BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fluorilaq

    Reg #: 3011632 · FEI: 3011632 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Pascal International, Inc.
    Registration Number
    3011632
    FEI Number
    3011632
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2929 Northup Way
    City
    Bellevue
    State
    WA
    ZIP
    98004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030488

    Owner / Operator

    Firm Name
    Pascal International
    Operator Number
    3011632
    Address
    2929 Northup Way
    City
    Bellevue
    State
    WA
    Postal Code
    98004
    Country
    US
    Correspondent
    Elizabeth Williams

    Products

    Device Name Product Code
    Varnish, Cavity LBH

    Proprietary Names

    Fluorilaq Fluorilaq Unit Dose Fluorilaq Squeeze

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device