BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Blue Sky Plan - Ortho Module

    Reg #: 3003402534 · FEI: 3003402534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BLUE SKY BIO, LLC
    Registration Number
    3003402534
    FEI Number
    3003402534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    800 Liberty Drive
    City
    Libertyville
    State
    IL
    ZIP
    60048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180107

    Owner / Operator

    Firm Name
    BLUE SKY BIO, LLC
    Operator Number
    9040515
    Address
    800 Liberty Drive
    City
    Libertyville
    State
    IL
    Postal Code
    60048
    Country
    US
    Correspondent
    Michele - Kupcso

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    Blue Sky Plan - Ortho Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility