BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reclaim HD

    Reg #: 3013398957 · FEI: 3013398957 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Paragon Vision Sciences, Inc.
    Registration Number
    3013398957
    FEI Number
    3013398957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2120 W. Guadalupe Rd.
    City
    Gilbert
    State
    AZ
    ZIP
    85233
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221768

    Owner / Operator

    Firm Name
    COOPERVISION, INC.
    Operator Number
    9929062
    Address
    6101 Bollinger Canyon Road, Suite 500
    City
    San Ramon
    State
    CA
    Postal Code
    94583
    Country
    US

    Products

    Device Name Product Code
    Lens, Contact (Other Material) - Daily HQD

    Proprietary Names

    Reclaim HD PAG RGP Essential Oxfore 100

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198