BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hydro Fiber

    Reg #: 3010473074 · FEI: 3010473074 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WHK BIOSYSTEMS, LLC
    Registration Number
    3010473074
    FEI Number
    3010473074
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11345 53rd St N
    City
    Clearwater
    State
    FL
    ZIP
    33760
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242797

    Owner / Operator

    Firm Name
    WHK BioSystems, LLC / Bergman
    Operator Number
    10045062
    Address
    11345 53rd Street North
    City
    Clearwater
    State
    FL
    Postal Code
    33760
    Country
    US
    Correspondent
    Victoria Bergman

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    Hydro Fiber

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)