BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CAMLab Cranial Orthosis Helmet

    Reg #: 1000560772 · FEI: 1000560772 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOSCULPTOR CORPORATION
    Registration Number
    1000560772
    FEI Number
    1000560772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2480 W 82nd St Unit 1
    City
    Hialeah
    State
    FL
    ZIP
    33016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081787

    Owner / Operator

    Firm Name
    BioSculptor Corporation
    Operator Number
    10028416
    Address
    2480 West 82nd Street, #1, Bay 1A
    City
    Hialeah
    State
    FL
    Postal Code
    33016
    Country
    US
    Correspondent
    Mark J Mazloff

    Products

    Device Name Product Code
    Orthosis, Cranial, Laser Scan OAN
    Orthosis, Cranial MVA

    Proprietary Names

    CAMLab Cranial Orthosis Helmet BioSculptor kinderBAND

    Establishment Types

    Manufacture Medical Device